The management of renal cell carcinoma (RCC) has seen significant advancements in recent years with the introduction of novel therapeutic agents and combination regimens. Immune checkpoint inhibitors (ICIs) have revolutionized the treatment landscape, particularly for advanced and metastatic RCC, where ICI-based combinations have shown substantial improvements in survival outcomes. Dual immunotherapy combinations, such as nivolumab plus ipilimumab, and ICI-vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) combinations, including pembrolizumab with axitinib, nivolumab with cabozantinib, and pembrolizumab with lenvatinib, have demonstrated overall survival (OS) benefits in first-line treatment, redefining the standard of care for advanced RCC. Adjuvant pembrolizumab is also approved for resected high-risk RCC and is the only adjuvant therapy that prolongs the OS in RCC. Additionally, the development of belzutifan, a hypoxia-inducible factor-2 alpha inhibitor, offers a new treatment option for patients whose disease progresses after ICI and VEGF TKI therapies. Recent results from CONTACT-3 and TiNiVo-2 confirm that ICI rechallenge should be generally discouraged. This review provides a detailed overview of the current evidence supporting immune-based combinations and novel agents such as belzutifan, as well as insights into treatment sequencing strategies for RCC.
{"title":"Recent Developments in the Management of Renal Cell Cancer.","authors":"Yu-Wei Chen, Justine Panian, Brent Rose, Aditya Bagrodia, Rana R McKay","doi":"10.1200/OP-24-00875","DOIUrl":"https://doi.org/10.1200/OP-24-00875","url":null,"abstract":"<p><p>The management of renal cell carcinoma (RCC) has seen significant advancements in recent years with the introduction of novel therapeutic agents and combination regimens. Immune checkpoint inhibitors (ICIs) have revolutionized the treatment landscape, particularly for advanced and metastatic RCC, where ICI-based combinations have shown substantial improvements in survival outcomes. Dual immunotherapy combinations, such as nivolumab plus ipilimumab, and ICI-vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) combinations, including pembrolizumab with axitinib, nivolumab with cabozantinib, and pembrolizumab with lenvatinib, have demonstrated overall survival (OS) benefits in first-line treatment, redefining the standard of care for advanced RCC. Adjuvant pembrolizumab is also approved for resected high-risk RCC and is the only adjuvant therapy that prolongs the OS in RCC. Additionally, the development of belzutifan, a hypoxia-inducible factor-2 alpha inhibitor, offers a new treatment option for patients whose disease progresses after ICI and VEGF TKI therapies. Recent results from CONTACT-3 and TiNiVo-2 confirm that ICI rechallenge should be generally discouraged. This review provides a detailed overview of the current evidence supporting immune-based combinations and novel agents such as belzutifan, as well as insights into treatment sequencing strategies for RCC.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2400875"},"PeriodicalIF":4.7,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
SriVarsha Katoju, Oliver T Nguyen, Sahana Rajasekhara, Young-Rock Hong, Amir Alishahi Tabriz, Kea Turner
Purpose: The use of electronic patient-reported outcome measures (ePROMs) in supportive cancer care can lead to benefits, such as identifying at-risk patients in need of closer monitoring and treatment. Despite these benefits, most studies examining ePROMs in this area were for clinical trials rather than standard care. Since there is a need to identify which patients are more likely to participate in ePROMs, this study assessed ePROM participation rates and factors influencing greater participation among patients receiving supportive care.
Methods: This retrospective data analysis took place at a supportive care clinic within a National Cancer Institute-designated Comprehensive Cancer Center in the southeastern United States. Starting in 2017, ePROM assessments were implemented using tablets for in-person appointments at the clinic. The assessments included the Patient Health Questionnaire-9, National Comprehensive Cancer Network Distress Thermometer, and Edmonton Symptom Assessment System with additional questions added for other symptoms. Logistic regression and zero-truncated negative binomial regression models were used to analyze factors associated with ePROM assessment submission.
Results: The study included 4,780 patients, with 42.7% submitting at least one ePROM assessment. Higher odds of ePROM submission were observed among patients age 35-64 years, had Medicare, had nonmetastatic cancer, or had genitourinary, breast, or multiple cancers. Additionally, higher rates of ePROM submissions were observed among patients who were younger; had GI, breast, or multiple cancers; had nonmetastatic cancer; or had private insurance.
Conclusion: This study reveals that submission rates of ePROM assessments in a cancer center's supportive care clinic may be influenced by patient demographics, cancer history, and social determinants of health. Interventions to improve ePROM submission rates may need to be tailored on the basis of cancer site, presence of metastatic cancer, and caregiver support.
{"title":"Participation in Electronic Patient-Reported Outcome Measures Collection as a Part of Routine Supportive Care Delivery in Oncology.","authors":"SriVarsha Katoju, Oliver T Nguyen, Sahana Rajasekhara, Young-Rock Hong, Amir Alishahi Tabriz, Kea Turner","doi":"10.1200/OP-24-00760","DOIUrl":"https://doi.org/10.1200/OP-24-00760","url":null,"abstract":"<p><strong>Purpose: </strong>The use of electronic patient-reported outcome measures (ePROMs) in supportive cancer care can lead to benefits, such as identifying at-risk patients in need of closer monitoring and treatment. Despite these benefits, most studies examining ePROMs in this area were for clinical trials rather than standard care. Since there is a need to identify which patients are more likely to participate in ePROMs, this study assessed ePROM participation rates and factors influencing greater participation among patients receiving supportive care.</p><p><strong>Methods: </strong>This retrospective data analysis took place at a supportive care clinic within a National Cancer Institute-designated Comprehensive Cancer Center in the southeastern United States. Starting in 2017, ePROM assessments were implemented using tablets for in-person appointments at the clinic. The assessments included the Patient Health Questionnaire-9, National Comprehensive Cancer Network Distress Thermometer, and Edmonton Symptom Assessment System with additional questions added for other symptoms. Logistic regression and zero-truncated negative binomial regression models were used to analyze factors associated with ePROM assessment submission.</p><p><strong>Results: </strong>The study included 4,780 patients, with 42.7% submitting at least one ePROM assessment. Higher odds of ePROM submission were observed among patients age 35-64 years, had Medicare, had nonmetastatic cancer, or had genitourinary, breast, or multiple cancers. Additionally, higher rates of ePROM submissions were observed among patients who were younger; had GI, breast, or multiple cancers; had nonmetastatic cancer; or had private insurance.</p><p><strong>Conclusion: </strong>This study reveals that submission rates of ePROM assessments in a cancer center's supportive care clinic may be influenced by patient demographics, cancer history, and social determinants of health. Interventions to improve ePROM submission rates may need to be tailored on the basis of cancer site, presence of metastatic cancer, and caregiver support.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2400760"},"PeriodicalIF":4.7,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Veronica Mears, Nikolas Naleid, Omkar Pawar, Jennifer Eva Selfridge, Madison Conces, Melissa Lumish, David Bajor, Amit Mahipal, Sakti Chakrabarti
Purpose: The combination of capecitabine and oxaliplatin (CAPOX) is commonly used in patients with localized colorectal cancer (CRC) receiving curative-intent treatment. Our study aimed to assess the real-world tolerability of CAPOX in a single-institution cohort of patients with localized CRC.
Methods: This is a single-institution retrospective study that included patients with localized CRC receiving neoadjuvant or adjuvant CAPOX. The primary end point was completion rate of intended number (obtained by chart review) of CAPOX cycles irrespective of dose levels. Secondary outcome measures included the rate of grade ≥3 adverse events, hospital admission rate, and dose reductions.
Results: The study included 153 patients with a median age of 61 years; 49% were female and 78.4% had stage III CRC. The proportion of patients (95% CI) who completed all planned CAPOX cycles was 44.4% (36 to 52) in the entire cohort and 34.6% (23 to 45) among female patients. Independent variables associated with treatment completion in multivariable analysis were race, sex, and intended number of cycles. Notably, the therapy completion rates (95% CI) were 55% (43 to 66) and 33% (20 to 45) in patients intended to receive four and eight cycles of CAPOX, respectively. The rate of grade ≥3 adverse events and hospitalization because of CAPOX-related toxicity were 30.7% (95% CI, 23 to 38) and 17.6% (95% CI, 11 to 23), respectively.
Conclusion: This study highlights that a substantial number of patients with localized CRC undergoing curative-intent treatment with CAPOX do not complete the planned cycles of chemotherapy because of toxicity. These findings underscore the need for careful patient selection and appropriate supportive care to optimize the therapeutic benefit of CAPOX in this setting.
{"title":"Real-World Tolerability of Capecitabine and Oxaliplatin in Patients in the United States With Localized Colorectal Cancer Undergoing Curative-Intent Treatment.","authors":"Veronica Mears, Nikolas Naleid, Omkar Pawar, Jennifer Eva Selfridge, Madison Conces, Melissa Lumish, David Bajor, Amit Mahipal, Sakti Chakrabarti","doi":"10.1200/OP-24-00647","DOIUrl":"https://doi.org/10.1200/OP-24-00647","url":null,"abstract":"<p><strong>Purpose: </strong>The combination of capecitabine and oxaliplatin (CAPOX) is commonly used in patients with localized colorectal cancer (CRC) receiving curative-intent treatment. Our study aimed to assess the real-world tolerability of CAPOX in a single-institution cohort of patients with localized CRC.</p><p><strong>Methods: </strong>This is a single-institution retrospective study that included patients with localized CRC receiving neoadjuvant or adjuvant CAPOX. The primary end point was completion rate of intended number (obtained by chart review) of CAPOX cycles irrespective of dose levels. Secondary outcome measures included the rate of grade ≥3 adverse events, hospital admission rate, and dose reductions.</p><p><strong>Results: </strong>The study included 153 patients with a median age of 61 years; 49% were female and 78.4% had stage III CRC. The proportion of patients (95% CI) who completed all planned CAPOX cycles was 44.4% (36 to 52) in the entire cohort and 34.6% (23 to 45) among female patients. Independent variables associated with treatment completion in multivariable analysis were race, sex, and intended number of cycles. Notably, the therapy completion rates (95% CI) were 55% (43 to 66) and 33% (20 to 45) in patients intended to receive four and eight cycles of CAPOX, respectively. The rate of grade ≥3 adverse events and hospitalization because of CAPOX-related toxicity were 30.7% (95% CI, 23 to 38) and 17.6% (95% CI, 11 to 23), respectively.</p><p><strong>Conclusion: </strong>This study highlights that a substantial number of patients with localized CRC undergoing curative-intent treatment with CAPOX do not complete the planned cycles of chemotherapy because of toxicity. These findings underscore the need for careful patient selection and appropriate supportive care to optimize the therapeutic benefit of CAPOX in this setting.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2400647"},"PeriodicalIF":4.7,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael J Robinson, Sang Minh Nguyen, Debra L Friedman, Emma A Schremp, Lucy L Wang, Scott C Borinstein, Elizabeth J Davis, Tuya Pal, Ben H Park, Xiao-Ou Shu
Purpose: Prevalence and risk factors for depression among patients with sarcoma and survivors of sarcoma are not well characterized.
Methods: A sarcoma survivorship cohort was constructed from patients diagnosed between April 2022 and September 2023. Depression symptoms were assessed via the eight-item Patient-Reported Outcomes Measurement Information System-57 depression scale at enrollment. Standardized T-score levels (<50, 50-59, and ≥60) were calculated and evaluated in association with demographics, lifestyle characteristics, clinical data, and modifiable factors using multinomial logistic regression models.
Results: Among 612 participants, the mean T-score was 48.3 (standard deviation, 10.0); 58.8% had a T-score <50, 27.9% scored between 50 and 59, and 13.2% scored ≥60. Participants age 18-39 years and age 40-59 years were more likely to have a T-score ≥60, with respective odds ratios (ORs) of 3.65 (95% CIs, 1.70 to 7.83) and 2.80 (1.52 to 5.17) compared with participants older than 60 years. Household incomes of $70,000-$120,000 in US dollars (USD) (OR, 0.46 [95% CI, 0.23 to 0.92]) and >$120,000 USD (OR, 0.15 [95% CI, 0.06 to 0.37]) were inversely associated with T-score ≥60 compared with household incomes <$45,000 USD. Marijuana use within the past 30 days was positively (OR, 3.48 [95% CI, 1.46 to 8.27]) associated, while regular exercise (OR, 0.43 [95% CI, 0.24 to 0.75]) and emotional support (OR, 0.37 [95% CI, 0.28 to 0.48]) were inversely associated with having T-score ≥60.
Conclusion: A higher prevalence of depression symptoms was notable in younger participants, marijuana users, and households with lower incomes. Regular exercise and increased emotional support were inversely associated with depression symptoms. Our study provides information for developing personalized supportive care strategies to ameliorate depression symptoms among patients with sarcoma.
{"title":"Prevalence and Associated Factors for Depression Among Patients With Sarcoma.","authors":"Michael J Robinson, Sang Minh Nguyen, Debra L Friedman, Emma A Schremp, Lucy L Wang, Scott C Borinstein, Elizabeth J Davis, Tuya Pal, Ben H Park, Xiao-Ou Shu","doi":"10.1200/OP.24.00163","DOIUrl":"https://doi.org/10.1200/OP.24.00163","url":null,"abstract":"<p><strong>Purpose: </strong>Prevalence and risk factors for depression among patients with sarcoma and survivors of sarcoma are not well characterized.</p><p><strong>Methods: </strong>A sarcoma survivorship cohort was constructed from patients diagnosed between April 2022 and September 2023. Depression symptoms were assessed via the eight-item Patient-Reported Outcomes Measurement Information System-57 depression scale at enrollment. Standardized <i>T</i>-score levels (<50, 50-59, and ≥60) were calculated and evaluated in association with demographics, lifestyle characteristics, clinical data, and modifiable factors using multinomial logistic regression models.</p><p><strong>Results: </strong>Among 612 participants, the mean <i>T</i>-score was 48.3 (standard deviation, 10.0); 58.8% had a <i>T</i>-score <50, 27.9% scored between 50 and 59, and 13.2% scored ≥60. Participants age 18-39 years and age 40-59 years were more likely to have a <i>T</i>-score ≥60, with respective odds ratios (ORs) of 3.65 (95% CIs, 1.70 to 7.83) and 2.80 (1.52 to 5.17) compared with participants older than 60 years. Household incomes of $70,000-$120,000 in US dollars (USD) (OR, 0.46 [95% CI, 0.23 to 0.92]) and >$120,000 USD (OR, 0.15 [95% CI, 0.06 to 0.37]) were inversely associated with <i>T</i>-score ≥60 compared with household incomes <$45,000 USD. Marijuana use within the past 30 days was positively (OR, 3.48 [95% CI, 1.46 to 8.27]) associated, while regular exercise (OR, 0.43 [95% CI, 0.24 to 0.75]) and emotional support (OR, 0.37 [95% CI, 0.28 to 0.48]) were inversely associated with having <i>T</i>-score ≥60.</p><p><strong>Conclusion: </strong>A higher prevalence of depression symptoms was notable in younger participants, marijuana users, and households with lower incomes. Regular exercise and increased emotional support were inversely associated with depression symptoms. Our study provides information for developing personalized supportive care strategies to ameliorate depression symptoms among patients with sarcoma.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2400163"},"PeriodicalIF":4.7,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143557086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura B Beidler, Kimberly Zayhowski, Mary Nahorniak, Stephanie Loo, Gretchen A Gignac, Catharine Wang, Christine M Gunn
Purpose: Many patients with prostate cancer are eligible for germline genetic testing, but it is underutilized in clinical practice. We aimed to explore perceptions of and decision making about undergoing genetic testing among patients with prostate cancer.
Methods: This qualitative interview study enrolled patients diagnosed with prostate cancer who had been treated at a safety-net hospital and had received a referral for genetic testing in the previous 12 months. Participants completed an interview in their native language via telephone. Data on genetic testing use were captured in interviews and via the medical record. A thematic analysis explored factors related to decision making in concert with genetic testing use.
Results: Thirty-three English-speaking (n = 25), Spanish-speaking (n = 6), and Haitian Creole-speaking (n = 2) patients completed interviews. In interviews, 19 reported completing genetic testing, 10 reported no testing, and four were unsure. Medical records indicated 24 had undergone genetic testing-including six participants whose self-reported testing status was no or unsure. Four main themes identified factors that influenced participant-reported genetic testing decisions: gendered perceptions of value to family, personal utility of genetic results, preferences for information, and relative priority of testing. Many participants did not view testing as a priority and delayed or declined testing because of cancer treatment burden.
Conclusion: These results suggest opportunities to improve communication about testing purpose, value, and utility in those affected by cancer. Conversations about the utility of both the individual benefit of obtaining genetic testing for those affected by prostate cancer and implications for familial cascade testing are warranted.
{"title":"Perceptions and Use of Germline Genetic Testing Among Patients With Prostate Cancer.","authors":"Laura B Beidler, Kimberly Zayhowski, Mary Nahorniak, Stephanie Loo, Gretchen A Gignac, Catharine Wang, Christine M Gunn","doi":"10.1200/OP-24-00624","DOIUrl":"https://doi.org/10.1200/OP-24-00624","url":null,"abstract":"<p><strong>Purpose: </strong>Many patients with prostate cancer are eligible for germline genetic testing, but it is underutilized in clinical practice. We aimed to explore perceptions of and decision making about undergoing genetic testing among patients with prostate cancer.</p><p><strong>Methods: </strong>This qualitative interview study enrolled patients diagnosed with prostate cancer who had been treated at a safety-net hospital and had received a referral for genetic testing in the previous 12 months. Participants completed an interview in their native language via telephone. Data on genetic testing use were captured in interviews and via the medical record. A thematic analysis explored factors related to decision making in concert with genetic testing use.</p><p><strong>Results: </strong>Thirty-three English-speaking (n = 25), Spanish-speaking (n = 6), and Haitian Creole-speaking (n = 2) patients completed interviews. In interviews, 19 reported completing genetic testing, 10 reported no testing, and four were unsure. Medical records indicated 24 had undergone genetic testing-including six participants whose self-reported testing status was no or unsure. Four main themes identified factors that influenced participant-reported genetic testing decisions: gendered perceptions of value to family, personal utility of genetic results, preferences for information, and relative priority of testing. Many participants did not view testing as a priority and delayed or declined testing because of cancer treatment burden.</p><p><strong>Conclusion: </strong>These results suggest opportunities to improve communication about testing purpose, value, and utility in those affected by cancer. Conversations about the utility of both the individual benefit of obtaining genetic testing for those affected by prostate cancer and implications for familial cascade testing are warranted.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2400624"},"PeriodicalIF":4.7,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: Conflicts of interest (COIs) in medical research can introduce biases affecting research integrity. This study investigated the scale and disclosure of COIs among Japanese authors of cancer clinical trials.
Methods: Fifty-eight cancer randomized controlled trials from 2020, involving 226 Japanese authors, were systematically abstracted and analyzed. The financial relationships between these authors and pharmaceutical companies were examined using payment data from 56 companies for the years 2018-2019. COI statements were extracted from each publication, and COI declaration rates were calculated by comparing declared companies against those that reported payments. The analysis was conducted at both the author and article levels. For author-level analyses, the declaration rate was calculated per declaration rather than per author. For article-level analyses, payments were aggregated and attributed to their respective articles.
Results: Phase III trials comprised 82.8% (48/58) of the included studies. Of 226 authors, 202 (89.4%) were medical doctors and 208 (92.0%) received at least one payment. The median number of companies providing at least one payment per author was 9 (IQR, 4-12), with a median total payment of $19,183 US dollars (USD; IQR, $5,158-$62,534 USD). Among 280 unique disclosures from authors with payments, only 29 (10.4%) accurately reported COIs, whereas 80 (28.6%) reported no COIs. For 58 articles, only two (3.4%) accurately reported COIs, seven (12.1%) reported no COIs, and 49 (84.5%) partially disclosed COI information.
Conclusion: Japanese cancer clinical trial authors frequently received industry payments, yet their COI disclosures were often inadequate. This highlights the need for stricter guidelines and improved education on COI reporting in Japan.
{"title":"Undisclosed Conflicts of Interest in Japanese Cancer Clinical Trials: A Cross-Sectional Study of Author-Pharmaceutical Industry Financial Relationships.","authors":"Hisanori Murasawa, Naoki Shin, Hikaru Miyata, Chihaya Saito, Tetsuya Tanimoto, Hiroaki Saito, Hayase Hakariya, Barbara Mintzes, Akihiko Ozaki","doi":"10.1200/OP-24-00768","DOIUrl":"https://doi.org/10.1200/OP-24-00768","url":null,"abstract":"<p><strong>Purpose: </strong>Conflicts of interest (COIs) in medical research can introduce biases affecting research integrity. This study investigated the scale and disclosure of COIs among Japanese authors of cancer clinical trials.</p><p><strong>Methods: </strong>Fifty-eight cancer randomized controlled trials from 2020, involving 226 Japanese authors, were systematically abstracted and analyzed. The financial relationships between these authors and pharmaceutical companies were examined using payment data from 56 companies for the years 2018-2019. COI statements were extracted from each publication, and COI declaration rates were calculated by comparing declared companies against those that reported payments. The analysis was conducted at both the author and article levels. For author-level analyses, the declaration rate was calculated per declaration rather than per author. For article-level analyses, payments were aggregated and attributed to their respective articles.</p><p><strong>Results: </strong>Phase III trials comprised 82.8% (48/58) of the included studies. Of 226 authors, 202 (89.4%) were medical doctors and 208 (92.0%) received at least one payment. The median number of companies providing at least one payment per author was 9 (IQR, 4-12), with a median total payment of $19,183 US dollars (USD; IQR, $5,158-$62,534 USD). Among 280 unique disclosures from authors with payments, only 29 (10.4%) accurately reported COIs, whereas 80 (28.6%) reported no COIs. For 58 articles, only two (3.4%) accurately reported COIs, seven (12.1%) reported no COIs, and 49 (84.5%) partially disclosed COI information.</p><p><strong>Conclusion: </strong>Japanese cancer clinical trial authors frequently received industry payments, yet their COI disclosures were often inadequate. This highlights the need for stricter guidelines and improved education on COI reporting in Japan.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2400768"},"PeriodicalIF":4.7,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vishnu Nagalapuram, Niveditha Popuri, Ryan D Nipp, Susanna V Ulahannan, Kelsey S Lau-Min
Global incidence of hepatocellular carcinoma (HCC) is rising along with its mortality burden, and more than half of the patients require systemic therapy for advanced disease. There is an ongoing epidemiologic shift in risk factors for HCC from hepatotropic virus-related liver disease to alcohol and metabolic dysfunction-associated steatotic liver disease. Although a diagnosis of HCC can be made with noninvasive radiologic criteria, tissue biopsy is gaining a role, at least within the realm of clinical trials. Despite advances in targeted therapies, the role of molecular testing in HCC remains unclear. Liver function continues to play a vital role in the management of HCC across all stages. With the approval of immune checkpoint inhibitors and tyrosine kinase inhibitors targeting tumor angiogenesis, the treatment landscape of advanced HCC has evolved considerably in the past decade, leading to improvements in patient outcomes. However, optimal sequencing of these agents is not well defined. There are several ongoing trials evaluating systemic therapies with novel mechanisms of action including adoptive cell therapy. This review aims to provide practicing oncologists with a comprehensive overview of recent developments in systemic therapy for the management of advanced HCC.
{"title":"Management of Advanced Hepatocellular Carcinoma: A Review and Practical Guide.","authors":"Vishnu Nagalapuram, Niveditha Popuri, Ryan D Nipp, Susanna V Ulahannan, Kelsey S Lau-Min","doi":"10.1200/OP-24-00872","DOIUrl":"https://doi.org/10.1200/OP-24-00872","url":null,"abstract":"<p><p>Global incidence of hepatocellular carcinoma (HCC) is rising along with its mortality burden, and more than half of the patients require systemic therapy for advanced disease. There is an ongoing epidemiologic shift in risk factors for HCC from hepatotropic virus-related liver disease to alcohol and metabolic dysfunction-associated steatotic liver disease. Although a diagnosis of HCC can be made with noninvasive radiologic criteria, tissue biopsy is gaining a role, at least within the realm of clinical trials. Despite advances in targeted therapies, the role of molecular testing in HCC remains unclear. Liver function continues to play a vital role in the management of HCC across all stages. With the approval of immune checkpoint inhibitors and tyrosine kinase inhibitors targeting tumor angiogenesis, the treatment landscape of advanced HCC has evolved considerably in the past decade, leading to improvements in patient outcomes. However, optimal sequencing of these agents is not well defined. There are several ongoing trials evaluating systemic therapies with novel mechanisms of action including adoptive cell therapy. This review aims to provide practicing oncologists with a comprehensive overview of recent developments in systemic therapy for the management of advanced HCC.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2400872"},"PeriodicalIF":4.7,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01Epub Date: 2024-08-02DOI: 10.1200/OP-24-00501
Arjun Gupta, Michelle Tregear, Makala B Pace, Rachel I Vogel
Time and other considerations when evaluating a switch to newer drug formulations (eg, subQ vs IV).
评估改用较新药物配方(例如,亚急性与静脉注射)时的时间和其他考虑因素。
{"title":"Stick With Intravenous or Give Subcutaneous a Shot? Time and Other Considerations When Evaluating Cancer Drug Formulations.","authors":"Arjun Gupta, Michelle Tregear, Makala B Pace, Rachel I Vogel","doi":"10.1200/OP-24-00501","DOIUrl":"10.1200/OP-24-00501","url":null,"abstract":"<p><p>Time and other considerations when evaluating a switch to newer drug formulations (eg, subQ vs IV).</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"267-269"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11787399/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01Epub Date: 2024-08-22DOI: 10.1200/OP.24.00033
Alfredo V Chua, Jennifer Delmerico, Haiyang Sheng, Xin-Wei Huang, Emily Liang, Li Yan, Shipra Gandhi, Igor Puzanov, Prantesh Jain, Lori C Sakoda, Gary R Morrow, Christine B Ambrosone, Charles Kamen, Song Yao
Purpose: Minoritized racial/ethnic groups are historically under-represented in cancer clinical trials, which may be exacerbated in recent trials on immune checkpoint inhibitors (ICIs). We examined the representation and reporting of the racial/ethnic composition of participants in clinical trials on ICIs.
Methods: We examined English full-text trials on ICIs published from 2007 to 2022. Information on trial characteristics and racial/ethnic composition of participants was extracted from published papers or ClinicalTrials.gov. Differences in participation by publication year, ICI agent, and cancer site were analyzed. Enrollment-incidence ratio (EIR) was calculated to compare the proportion of minoritized racial/ethnic group patients in US-based trials against age-adjusted cancer incidence data available for the US population. An EIR > 1 signified over-representation, whereas an EIR <1 signified under-representation.
Results: Of the 471 trials examined, racial composition was unreported in 146 (31%), whereas Hispanic/Latinx ethnicity was unreported in 278 (59%). Only 30 (6%) trials reported race/ethnicity-specific results. In US-only trials (n = 174), White patients were over-represented (EIR, 1.20 [95% CI, 1.17 to 1.22]), whereas Hispanic/Latinx patients were the most under-represented (EIR, 0.35 [95% CI, 0.24 to 0.48]), followed by Black/African American patients (EIR, 0.66 [95% CI, 0.54 to 0.79]). Subgroup analyses consistently indicated over-representation of White patients across publication years (EIR, 1.19-1.24), ICI classes (EIR, 1.16-1.23), and cancer sites (EIR, 1.11-1.31), whereas Hispanic/Latinx patients were consistently under-represented. An upward trend of trial representation and reporting was observed for all minoritized racial/ethnic groups over time (trend P values ≤.05).
Conclusion: Disparities in the representation and reporting of minoritized racial/ethnic groups persist in recent trials on ICIs, necessitating collaborative efforts for improved diversity and equitable cancer treatment access.
{"title":"Under-Representation and Under-Reporting of Minoritized Racial and Ethnic Groups in Clinical Trials on Immune Checkpoint Inhibitors.","authors":"Alfredo V Chua, Jennifer Delmerico, Haiyang Sheng, Xin-Wei Huang, Emily Liang, Li Yan, Shipra Gandhi, Igor Puzanov, Prantesh Jain, Lori C Sakoda, Gary R Morrow, Christine B Ambrosone, Charles Kamen, Song Yao","doi":"10.1200/OP.24.00033","DOIUrl":"10.1200/OP.24.00033","url":null,"abstract":"<p><strong>Purpose: </strong>Minoritized racial/ethnic groups are historically under-represented in cancer clinical trials, which may be exacerbated in recent trials on immune checkpoint inhibitors (ICIs). We examined the representation and reporting of the racial/ethnic composition of participants in clinical trials on ICIs.</p><p><strong>Methods: </strong>We examined English full-text trials on ICIs published from 2007 to 2022. Information on trial characteristics and racial/ethnic composition of participants was extracted from published papers or ClinicalTrials.gov. Differences in participation by publication year, ICI agent, and cancer site were analyzed. Enrollment-incidence ratio (EIR) was calculated to compare the proportion of minoritized racial/ethnic group patients in US-based trials against age-adjusted cancer incidence data available for the US population. An EIR > 1 signified over-representation, whereas an EIR <1 signified under-representation.</p><p><strong>Results: </strong>Of the 471 trials examined, racial composition was unreported in 146 (31%), whereas Hispanic/Latinx ethnicity was unreported in 278 (59%). Only 30 (6%) trials reported race/ethnicity-specific results. In US-only trials (n = 174), White patients were over-represented (EIR, 1.20 [95% CI, 1.17 to 1.22]), whereas Hispanic/Latinx patients were the most under-represented (EIR, 0.35 [95% CI, 0.24 to 0.48]), followed by Black/African American patients (EIR, 0.66 [95% CI, 0.54 to 0.79]). Subgroup analyses consistently indicated over-representation of White patients across publication years (EIR, 1.19-1.24), ICI classes (EIR, 1.16-1.23), and cancer sites (EIR, 1.11-1.31), whereas Hispanic/Latinx patients were consistently under-represented. An upward trend of trial representation and reporting was observed for all minoritized racial/ethnic groups over time (trend <i>P</i> values ≤.05).</p><p><strong>Conclusion: </strong>Disparities in the representation and reporting of minoritized racial/ethnic groups persist in recent trials on ICIs, necessitating collaborative efforts for improved diversity and equitable cancer treatment access.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"408-417"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845527/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}