Quality of life in the trastuzumab for gastric cancer trial

Abstract

Background: The Trastuzumab for Gastric Cancer phase III trial demonstrated that combining trastuzumab with chemotherapy significantly improved overall survival compared with chemotherapy alone in HER2-positive advanced gastric or gastroesophageal junction cancer. We report health-related quality of life (HRQoL) and quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) results from this trial.

Patients and methods: Patients were randomized to receive six cycles of chemotherapy given every 3 weeks (capecitabine or fluorouracil, plus cisplatin) either alone or combined with administration of trastuzumab every 3 weeks until disease progression. At each clinical visit, HRQoL was assessed using two European Organization for Research and Treatment of Cancer quality of life questionnaires, QLQ-C30 and QLQ-STO22. Q-TWiST methodology was applied retrospectively using the clinical data and utility coefficients.

Results: Trastuzumab plus chemotherapy prolonged time to 10% definitive deterioration in all QLQ-C30 and QLQ-STO22 scores, including QLQ-C30 global health status versus chemotherapy alone, from 6.4 months to 10.2 months. In addition, trastuzumab plus chemotherapy extended Q-TWiST by 2.42 months compared with chemotherapy alone.

Conclusion: Compared with chemotherapy alone, trastuzumab plus chemotherapy prolongs time to deterioration of HRQoL and increases quality-adjusted survival in patients with HER2-positive gastric or gastroesophageal junction cancer.

Trial registration: ClinicalTrials.gov NCT01041404.

Keywords: Chemotherapy; Gastric cancer; HER2; Quality of life; Trastuzumab.

Figure 1.

Change from baseline global health status scores. (A): Initial analysis. (B): Follow-up analysis. Data are means and standard errors of the mean. Assessments were performed at baseline and then every 3 weeks until progression of disease or withdrawal. Data beyond 64 weeks are not presented due to the low number of patients whose disease progressed after this time point. Abbreviations: BL, baseline; C, chemotherapy; T, trastuzumab.

Figure 2.

Kaplan-Meier plots of time to a 10% definitive deterioration in European Organization for Research and Treatment of Cancer QLQ-C30 global health status for the full analysis set population (A) and for patients with high-level HER2 expression (immunohistochemistry [IHC] 2+/fluorescence in situ hybridization-positive or IHC 3+) (B). Abbreviations: C, chemotherapy; T, trastuzumab.

Figure 3.

Proportions of patients with European Organization for Research and Treatment of Cancer QLQ-C30 global health status scores improving by at least 10%, worsening by at least 10%, and with no change (improvement or worsening by <10%). Abbreviations: C, chemotherapy; T, trastuzumab.

Figure 4.

Time spent (months) in quality-adjusted TWiST (Q-TWiST) health states. (A): Unadjusted analysis: a = comparison of OS; b = comparison of PFS; c = comparison of TWiST. (B): Utility-adjusted analysis: c = comparison of TWiST; d = comparison of Q-TWiST. ∗p < .001. Abbreviations: C, chemotherapy; REL, disease relapse; T, trastuzumab; TOX, duration of toxicity; TWiST, time without disease symptoms or treatment toxicity.