JCO Global Oncology最新文献

Purpose: To compare overall survival (OS), toxicity, and quality of life (QOL) in patients with metastatic gallbladder cancer receiving oral capecitabine (X) with best supportive care (BSC) and BSC alone.

Materials and methods: Patients with metastatic gallbladder cancer and Karnofsky Performance Status (KPS) ≥70 were accrued and assigned to either arm A or B. Assignment to these two arms was based on physician/patient discretion. Arm A received oral capecitabine 825 mg/m² twice a day d1-14, repeated every 3 weeks for six cycles with BSC, and arm B received BSC alone. The Kaplan-Meier method computed OS and comparison was using a log-rank test. QOL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 administered at baseline, 3 months, and 6 months. The linear mixed-effects model was used for the longitudinal analysis of QOL.

Results: Between December 2020 and April 2022, 64 patients diagnosed with metastatic gallbladder carcinoma and KPS ≥70 were accrued in the study, and 32 patients were assigned to each arm. In arm A versus B, the median age was 52 versus 55 (P = .21); the median KPS was 80 versus 70 (P = .008). The median OS in arm A versus B was 3.4 versus 2 months (P = .001). Grade 1-2 vomiting and diarrhea were seen in 50% versus 78% (P = .041) and 59% versus 9.3% (P = .01) patients in arm A versus B, respectively. Grade 1-2 hand-foot syndrome was seen in 12 (37.5%) patients in arm A. Dynamic changes showed an improvement in pain in the linear mixed model with a significant difference between the arms (P = .011); arm A experienced a significant improvement in pain over time (arm × time P = .020). Global QOL improved over time (P = .038) with parallel improvement between arms (arm × time P = .490).

Conclusion: Compared with BSC alone, patients who receive X + BSC experience an OS improvement of 1.4 months and better pain control without grade 3 toxicities or negative impact on QOL.

Purpose: To analyze survival and its predictors among patients with hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in Ethiopia.

Materials and methods: We conducted a retrospective cohort study among patients who received TACE for HCC at MCM Hospital from December 1, 2016, to December 31, 2022. Data were extracted from patients' medical records, and vital status was ascertained from the patients' charts or by phone call to the next of kin. We used Kaplan-Meier estimator to determine survival functions and log-rank test to compare the survival functions in different groups. Predictors of survival were identified using a multivariable Cox proportional hazards regression model as expressed by adjusted hazard ratio (aHR).

Results: Of the total 257 patients included in the study, 68.9% were male, with a mean age of 56.5 (±14.06) years, and 86% were diagnosed at the advanced stage of the cancer (Barcelona Clinic Liver Cancer-C). The median overall survival was 12.7 months (95% CI, 10.57 to 14.85), and the overall survival rate at 1 year, 2 years, 3 years, 4 years, 5 years, and 6 years was found to be 58.0% (95% CI, 51.8% to 63.8%), 24.1% (95% CI, 19.1% to 29.6%), 8.2% (95% CI, 5.1% to 11.7%), 7.0% (95% CI, 3.9% to 10.1%), 1.6% (95% CI, 0.4% to 3.1%), and 1.2% (95% CI, 0.1% to 2.7%), respectively. The probability of death was significantly increased by alpha-fetoprotein level <400 ng/mL (aHR, 5.72 [95% CI, 1.52 to 21.51]), albumin level (aHR, 5.03 [95% CI, 1.41 to 18.01]), and bilobar distribution (aHR, 5.67 [95% CI, 1.40 to 23.04]).

Conclusion: The findings of the study underscore the need for the expansion of preventive measures and treatment facilities to address the overwhelming burden of HCC in Ethiopia.

Purpose: Asparaginase (ASN) is a critical component of pediatric ALL protocols. Until recently, ASN was available in three formulations: native Escherichia coli, PEGylated E. coli (PEG), and Erwinase, with native E. coli typically more accessible in low- and middle-income countries (LMICs). Short shelf lives, intermittent availability, and concern for substandard formulations in LMICs have created a need for proactive ASN demand estimates.

Methods: We adapted FORxECAST, a pediatric cancer drug forecasting model, to focus on ASN for pediatric ALL. The model is adaptable to user data and defaults to best available public data where local data are unavailable. We forecast ASN quantity and cost in three case study countries for four scenarios using two regimens-base regimen (BR) and intensified regimen (IR)-outlining how quantity and costs vary on the basis of ASN formulation, dose, and second-line availability.

Results: Native E. coli is cheaper than PEG for first-line treatment across all scenarios. Regimen intensification from BR to IR requires a substantially higher cost when PEG is used relative to native E. coli. The cost of treating ASN hypersensitivity with Erwinase for BR in Burundi, Ghana, and Turkmenistan is $19,660 in US dollars (USD), $24,800 USD, and $15,246 USD, respectively.

Conclusion: Treatment intensification requires a cost increase that should be accessible for most LMICs, but PEG utilization is substantially more costly, suggesting that prioritizing investment in intensifying treatment using native E. coli is the least costly approach to maximize treatment availability. Cost savings associated with native E. coli utilization may liberate funds for Erwinase procurement for patients with ASN hypersensitivity. Future analyses needed include an evaluation of costs associated with preventing abandonment due to compliance complexity with native E. coli given increased administration frequency compared with PEG.

Purpose: Moderate hypofractionation (MHF) offers logistical and financial advantages, and has become standard in Western countries but not yet in Africa. This study assessed GI and genitourinary (GU) acute toxicity in Rwandan men undergoing MHF (20 × 3 Gy) treatment.

Materials and methods: Since 2021, patients with prostate cancer at the Rwanda Cancer Centre have been informed about the study on MHF treatment and could participate by signing an informed consent. The study included patients with confirmed prostate adenocarcinoma (any T, any prostate-specific antigen any Gleason score, N0M0), excluding those with inflammatory bowel disease, previous pelvic irradiation, or previous prostatectomy. Participants received 20 fractions of 3 Gy over 4 weeks using the volumetric modulated arc radiotherapy (RT) technique with a 6 megavoltage linear accelerator. GI and GU acute toxicity was evaluated at week 2, at the end of RT, and 3 months after treatment using the Radiation Therapy Oncology Group (RTOG) acute toxicity grading system.

Results: Fifty consecutive patients with localized prostate cancer were included. The median patient age was 70 years. Most patients (86%) had high-risk disease and 94% received androgen-deprivation therapy. The cost and treatment time were reduced by 50%. The distribution of maximum acute RTOG toxicity scores were for GI 10% grade 0, 70% grade 1, 20% grade 2, 0% grade 3, and for GU scores were 0%, 40%, 54%, and 6%, respectively. By 3 months, RT symptoms had returned to baseline levels for most patients.

Conclusion: MHF (20 × 3 Gy) was well tolerated in men treated for prostate cancer in Rwanda, showing that MHF is feasible in an African setting. However, further research on acute and late toxicity for more patients is warranted.

Purpose: This manuscript reports the results of the Indian Network for Development of Peritoneal Surface Oncology and Indian Society of Peritoneal Surface Malignancies (INDEPSO-ISPSM) consensus that aimed to provide recommendations for some important aspects management of patients with colorectal peritoneal metastases (CPM) and address some issues unique to India.

Methods: The modified Delphi technique was used with two rounds of voting. There were 29 questions on nine main topics-the role of cytoreductive surgery (CRS), patient selection for CRS, preoperative workup, role of systemic chemotherapy (SC), CPM with other visceral metastases, molecular profile, hyperthermic intraperitoneal chemotherapy (HIPEC) and other modalities of intraperitoneal chemotherapy (IPC), prophylactic/preventive strategies, and surveillances after CRS. A consensus was achieved if anyone option received >70 votes (strong consensus >90%).

Results: Forty-eight surgical (n = 41) and gastrointestinal (n = 7) oncologists were invited; 44 agreed to participate. The response rate was 95.4% (42/44) in round 1 and 93.1% (41/44) in round 2. Overall, a consensus was achieved on 23/29 (79.3%) questions (strong consensus on 6/29 [20.6%]). The panel strongly recommended considering surgery for limited CPM with limited liver metastases (92.5%), not altering the surgical approach in patients with KRAS mutations (91.67%), and limiting the use of IPC for unresectable CPM outside clinical trials (95%). Adjuvant SC was recommended for all patients undergoing CRS (89.47%). CRS is a therapeutic option for selected patients with CPM including those with metachronous CPM (79.49) and signet ring cell cancers (76.92%). HIPEC was recommended outside clinical trials only for patients with peritoneal cancer index 11-15(80%).

Conclusion: The panel recommended CRS for most indications but was very selective in recommending HIPEC and IPC outside clinical trials. These recommendations should be a useful resource in clinical decision making for clinicians treating CPM in India and regions with a similar sociodemographic background.

Cancer remains a widespread and significant global health issue, with consequential impacts on individuals, families, and societies across the globe. Although there have been noteworthy advancements in the prevention, diagnosis, treatment, and study of cancer, the impact of this disease continues to be significant on health care systems and people worldwide. Furthermore, there are still differences in obtaining the advantages of modern cancer treatment, which can partly be attributed to the lack of standardized standards for providing top-notch cancer care. To tackle these difficulties, a multitude of projects and organizations have emerged to address the standard of cancer care on a global level. This paper provides a comprehensive review and analysis of the worldwide influence of programs and organizations that seek to improve the quality of cancer care. This document examines the progression of these initiatives, their cooperation with international organizations, possible paths for additional advancement, and suggestions for enhancing the standard of cancer treatment worldwide.

Purpose: Targeted therapies are indicated for patients with non-small cell lung cancer (NSCLC) and driver tumor mutations. However, real-world studies on the survival benefits of these agents are limited. This study aimed to evaluate the effect of targeted therapies matched to a genomic alteration on the survival of patients with NSCLC.

Methods: This retrospective study included 446 patients with advanced NSCLC who underwent next-generation sequencing between 2016 and 2023 at the Instituto Nacional de Cancerología in Mexico. The primary outcomes were progression-free survival (PFS) and overall survival (OS).

Results: For the entire cohort, the PFS and OS were 10.71 months (95% CI, 9.35 to 12.06) and 47.77 months (95% CI, 29.67 to 65.86). PFS was significantly longer in patients with actionable mutations treated with targeted therapies (19.41 months [95% CI, 14.27 to 24.55]; P < .001) than in patients without actionable mutations (6.4 months [95% CI, 4.4 to 8.4]) or not treated with targeted therapies (6.6 months [95% CI, 5.3 to 7.89]). Similarly, OS was significantly longer in patients with actionable mutations treated with targeted therapies (89.69 months [95% CI, 45.54 to 133.84]; P < .001) than in patients without actionable mutations (17.11 months [95% CI, 8.65 to 25.57]) or not treated with targeted therapies (22.3 months [95% CI, 12.48 to 32.1]). Survival gains were driven by significant improvements in PFS and OS in patients with EGFR and ALK mutations.

Conclusion: This real-world data analysis demonstrated that targeted therapies improve the survival of patients with NSCLC with actionable mutations, which supports a recommendation for widening access to broad-based genomic testing and targeted therapies.

Purpose: Breast cancer (BC) is the most common female cancer worldwide, and the burden is increasing across sub-Saharan Africa. For women with hormone receptor-positive (HR+) cancers, endocrine therapy (ET) taken for 5-10 years can reduce the risk of recurrence by half. We explored experiences with ET and barriers to utilization among survivors in Botswana.

Methods: We recruited women with nonmetastatic disease from a survivorship cohort who had undergone mastectomy within 1-5 years for semi-structured interviews to explore experiences with treatment. This thematic content analysis focused on ET, so the sample included women with HR+ cancer who should have received ET and HR- women who reported taking ET.

Results: We analyzed interviews with 19 women (mean age 54 years, 42% stage I/II, 58% stage III). Three key themes were identified: (1) limited provider counseling, (2) challenges refilling prescriptions at public pharmacies, and (3) high medication and transportation costs associated with private pharmacies. Subthemes included immunohistochemistry result communication, lack of knowledge, frequent public pharmacy stockouts, inconvenient prescription refill policies, and medication switching and discontinuation, especially among participants with low socioeconomic positions (SEPs). Women's persistence, SEP, and financial support facilitated refills. Although some experienced side effects, they were not a common reason for discontinuation.

Conclusion: BC survivors in Botswana face multilevel barriers to accessing and adhering to ET. Provider and health system improvements are needed to effectively communicate ET importance and increase access to consistently available and affordable medication.

Purpose: The burden of cervical cancer in India is enormous, with more than 60,000 deaths being reported in 2020. The key intervention in the WHO's global strategy for the elimination of cervical cancer is to aim for the treatment and care of 90% of women diagnosed with cervical lesions. The current screen-and-treat approach as an option for resource-limited health care systems where screening of the cervix with visual inspection with acetic acid application (VIA) is followed by immediate ablative treatment by nurses in the case of a positive test. This approach often results in overtreatment, owing to the subjective nature of the test. Unnecessary treatments can be diminished with the use of emerging computer-assisted visual evaluation technology, using artificial intelligence (AI) tool to triage VIA-positive women. The aim of this study was (1) to develop a VIA-AI tool using cervical images to identify and categorize the VIA-screen-positive areas for eligibility and suitability for ablative treatment, and (2) to understand the efficacy of the VIA-AI tool in guiding the nurses to decide on treatment eligibility in the screen-and-treat cervical screening program.

Methods: This was an exploratory, interventional study. The VIA-AI tool was developed using deep-learning AI from the image bank collected in our previously conducted screening programs. This VIA-AI tool was then pilot-tested in an ongoing nurse-led VIA screening program.

Results: A comparative assessment of the cervical features performed in all women using the VIA-AI tool showed clinical accuracy of 76%. The perceived challenge rate for false positives was 20%.

Conclusion: This novel cervical image-based VIA-AI algorithm showed promising results in real-life settings, and could help minimize overtreatment in single-visit VIA screening and treatment programs in resource-constrained situations.