Babu K Govind, Chaudhuri Tamojit, Lakshmaiah K C, Dasappa Lokanatha, Jacob Linu Abraham, Suresh Babu M C, Rudresha A H, Lokesh K N, Rajeev L K
Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India.
South Asian J Cancer. 2018 Jan-Mar;7(1):11-15. doi: 10.4103/sajc.sajc_8_17.
Health-related quality of life (HRQOL) is an important oncologic end point for upper gastrointestinal malignancies. Unfortunately, till date, there is no published prospective data from India, comparing the HRQOL parameters between first-line chemotherapy regimens in advanced/metastatic gastric cancer.
The present study aimed to compare the HRQOL of first-line systemic chemotherapy with epirubicin, cisplatin plus 5-FU (ECF) and docetaxel, cisplatin plus 5-FU (DCF) regimens in patients with locally advanced inoperable or metastatic gastric or gastro-esophageal junction adenocarcinoma. The secondary end points were overall response rate, progression-free survival (PFS), overall survival (OS), and toxicity profile.
Between December 2014 and December 2016, 65 patients were treated with ECF ( = 34) or DCF ( = 31) regimen. The baseline HRQOL scores were comparable between the two study groups, with the exception of significantly poor pain and sleep difficulties symptom score in the DCF group. After three cycles of treatment, both the groups showed improvements in most of the quality of life (QOL) parameters including global QOL score, compared with their baseline status. After six cycles of chemotherapy, the ECF group showed nonsignificant deterioration for most of the QOL parameters; but on the contrary, the DCF group maintained improved scores for most of the QOL parameters. The median survival until a definitive deterioration of global QOL score was significantly better in the DCF arm in comparison to the ECF arm (7.1 vs. 5.6 months, respectively, = 0.000). The median OS was 9.2 months with ECF and 12.5 months with DCF regimen ( = 0.000), while median PFS was 5.7 and 7.4 months with ECF and DCF regimens, respectively ( = 0.002).
This prospective study highlighted a better impact of DCF chemotherapy on the HRQOL of patients with advanced/metastatic gastric cancer and showed the importance of QOL assessments in clinical trials to complement the risk-benefit judgment.
健康相关生活质量（HRQOL）是上消化道恶性肿瘤的一个重要肿瘤学终点。不幸的是，迄今为止，印度尚无已发表的前瞻性数据，比较晚期/转移性胃癌一线化疗方案之间的HRQOL参数。
本研究旨在比较表柔比星、顺铂联合5-氟尿嘧啶（ECF）和多西他赛、顺铂联合5-氟尿嘧啶（DCF）方案一线全身化疗对局部晚期不可切除或转移性胃癌或胃食管交界腺癌患者的HRQOL。次要终点为总缓解率、无进展生存期（PFS）、总生存期（OS）和毒性特征。
2014年12月至2016年12月期间，65例患者接受了ECF（n = 34）或DCF（n = 31）方案治疗。两个研究组的基线HRQOL评分相当，但DCF组的疼痛和睡眠困难症状评分明显较差。三个周期的治疗后，与基线状态相比，两组在包括总体生活质量评分在内的大多数生活质量（QOL）参数方面均有改善。六个周期的化疗后，ECF组的大多数QOL参数显示无显著恶化；但相反，DCF组的大多数QOL参数得分保持改善。与ECF组相比，DCF组直至总体QOL评分最终恶化的中位生存期显著更长（分别为7.1个月和5.6个月，P = 0.000）。ECF方案的中位OS为9.2个月，DCF方案为12.5个月（P = 0.000），而ECF和DCF方案的中位PFS分别为5.7个月和7.4个月（P = 0.002）。
这项前瞻性研究突出了DCF化疗对晚期/转移性胃癌患者HRQOL的更好影响，并显示了QOL评估在临床试验中对补充风险效益判断的重要性。
