Quality-of-life results of a randomized phase III trial of four cisplatin (Cis) containing doublet combinations in stage IVB cervical carcinoma: A gynecologic oncology group (GOG) study

Abstract

5529 Background: Women with stage IVB, recurrent or persistent cancer not amenable to cure were randomized to Cis (C) plus one of the following four drugs: paclitaxel (CP, Reference Arm); vinorelbine (CV); gemcitabine (CG); or Topotecan (CT). Quality of life (QOL) was evaluated in order to determine if CV, CG, or CT was associated with less neuropathy, less pain, or better QOL relative to CP. Methods: QOL was assessed prior to randomization (baseline), prior to cycles 2 and 5, and 9 months post study entry. QOL measures included the Functional Assessment of Cancer Therapy - Cervix Trial Outcome Index (FACT-Cx TOI), the FACT/GOG-Neurotoxicity 4- item scale, and the Brief Pain Inventory 0–10 pain intensity item. Results: The study was closed in April 2007 based on a planned interim analysis on clinical endpoints. By then, 81.8% of target accrual was enrolled (N=491). There was no statistically significant difference in the completion of QOL forms between groups. Baseline scores were comparable on all measures. From pre-cycle 2 through the 9- month follow-up, there were no clinically or statistically significant differences across any of the groups in pain or QOL. Power to detect a 0.5 SD difference between groups was better than 80% pre-cycle 2, but ranged from 22–67% for the last two assessments. Women on the CG and CT regimens reported less neuropathy at the last two assessments, although the difference was not statistically significant. In general, QOL and pain improved slightly over time and neuropathy worsened, showing no indication of improving at the 9-month assessment. Conclusions: No doublet was clinically or statistically different from CP in QOL or pain. A clinical advantage to CG and CT treatment is possible with regard to neurotoxicity, but low power might contribute to a lack of statistical significance. The survival and QOL data will be fully mature in spring 2008, providing more context for interpretation. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration GlaxoSmithKline GlaxoSmithKline