Hyperthermic intraperitoneal chemotherapy (HIPEC) vs. postoperative intraperitoneal (IP) chemotherapy – Impact on health-related quality of life in primary ovarian cancer patients after cytoreductive surgery

Luis Felipe Falla-Zuniga , Armando Sardi , Mary Caitlin King , Andrei Nikiforchin , Felipe Lopez-Ramirez , Philipp Barakat , Carol Nieroda , Vadim Gushchin , Teresa Diaz-Montes
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Abstract

Purpose

To compare health-related quality of life (HRQL) in primary ovarian cancer (OC) patients with peritoneal metastases (PM) after undergoing upfront cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) as part of a phase 2 trial (NCT-02124421).

Methods

Patients with stage III/IV high-grade serous OC were randomized (1:1) to either CRS/HIPEC with carboplatin followed by 6 cycles of adjuvant systemic chemotherapy (carboplatin/paclitaxel) or CRS followed by 6 cycles of combination intraperitoneal/intravenous chemotherapy (cisplatin/paclitaxel). The trial outcome index (TOI) of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess HRQL. The FACT-O was administered at randomization and postoperatively at 6 weeks and 6, 12, and 24 months, or until disease recurrence/death. HRQL was analyzed using a linear mixed model.

Results

Sixteen patients were enrolled in each group. All (32/32) patients completed questionnaires at baseline and 53.1 % (17/32) at 24 months. Reasons for missing scores were similar between groups. Average TOI was similar between treatment arms at each time point. In both arms, mean TOI was below baseline at 6 weeks (p = 0.798) and 6 months (p = 0.821) after CRS, but recovered at 12 months (p = 0.518). No significant differences were found in FACT-O total score or FACT-O individual dimensions over time between groups.

Conclusions

No long-term HRQL impairment was observed when HIPEC was added to CRS in primary OC. Access to CRS/HIPEC as primary treatment of PM in OC should not be solely limited by concerns for patient HRQL.

Synopsis

Health-related quality of life (HRQL) was evaluated in primary ovarian cancer patients participating in a phase 2 trial comparing cytoreductive surgery (CRS)/HIPEC vs CRS + intraperitoneal (IP) chemotherapy. No differences between groups or long-term HRQL impairment were observed.

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腹腔内热化疗 (HIPEC) 与术后腹腔内化疗 (IP) - 对原发性卵巢癌患者接受细胞切除手术后与健康相关的生活质量的影响
目的作为一项2期试验(NCT-02124421)的一部分,比较有腹膜转移(PM)的原发性卵巢癌(OC)患者在接受前期囊肿剥除手术并进行或不进行腹腔内热化疗(CRS/HIPEC)后的健康相关生活质量(HRQL)。方法将III/IV期高级别浆液性OC患者随机(1:1)分为两种,一种是CRS/HIPEC联合卡铂,然后进行6个周期的辅助全身化疗(卡铂/紫杉醇),另一种是CRS,然后进行6个周期的腹腔内/静脉联合化疗(顺铂/紫杉醇)。癌症治疗功能评估-卵巢(FACT-O)问卷的试验结果指数(TOI)用于评估HRQL。FACT-O 在随机化时和术后 6 周、6、12 和 24 个月或疾病复发/死亡前进行。采用线性混合模型对 HRQL 进行分析。所有患者(32/32)都在基线时填写了问卷,53.1%(17/32)的患者在 24 个月时填写了问卷。各组缺失分数的原因相似。各治疗组在每个时间点的平均TOI相似。两组患者在 CRS 后 6 周(p = 0.798)和 6 个月(p = 0.821)的平均 TOI 均低于基线,但在 12 个月时有所恢复(p = 0.518)。各组间的 FACT-O 总分或 FACT-O 单个维度随时间变化无明显差异。简要说明:对参与一项2期临床试验的原发性卵巢癌患者进行了健康相关生活质量(HRQL)评估,比较了囊肿切除手术(CRS)/HIPEC与CRS+腹腔内化疗(IP)。未观察到组间差异或长期 HRQL 损伤。
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