Quality of Life of Palliative Chemotherapy Naive Patients with Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction Treated with Irinotecan Combined with 5-Fluorouracil and Folinic Acid: Results of a Randomised Phase III Trial

• Published in: Quality of Life Research 2009-09, Vol.18 (7), p.853-861
• Main Authors: Curran, Desmond, Pozzo, Carmelo, Zaluski, Jerzy, Dank, Magdalena, Barone, Carlo, Valvere, Vahur, Yalcin, Suayib, Peschel, Christian, Wenczl, Miklós, Goker, Erdem, Bugat, Roland
• Format: Article
• Language: English
• Subjects: Adenocarcinoma; Adenocarcinoma - drug therapy; Adenocarcinoma - psychology; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Cancer; Chemotherapy; Cisplatin - administration & dosage; Clinical and Policy Applications; Esophagogastric Junction - pathology; Fluorouracil - administration & dosage; Gastric cancer; Humans; Leucovorin - administration & dosage; Mathematical minima; Medicine; Medicine & Public Health; Middle Aged; Missing data; Neoplasm Metastasis; Oncology; Palliative Care - methods; Public Health; Quality of Life; Quality of Life Research; Questionnaires; School dropouts; Sociology; Statistical methods; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; Stomach Neoplasms - psychology; Time windows; Young Adult
• ISSN: 0962-9343; 1573-2649; 1432-1203
• DOI: 10.1007/s11136-009-9493-z

Purpose The quality of life (QL) of advanced gastric cancer patients receiving irinotecan, folinic acid and 5-fluorouracil (5-FU) (IF arm) or cisplatin with 5-FU (CF arm) is presented. Methods Patients with measurable or evaluable advanced gastric cancer received IF weekly for 6/7 weeks or CF q4 weeks. QL was assessed using the EORTC QLQ-C30 at baseline, subsequently every 8 weeks until progression and thereafter every 3 months until death. The QL data were analysed using several statistical methods including summary measures and pattern-mixture modelling. Results A total of 333 patients were randomised and treated (IF 170, CF 163). The time-to-progression for IF and CF was 5.0 and 4.2 months (P = 0.088), respectively. The overall compliance rates for QL questionnaire completion were 60 and 56% in the IF and CF arms, respectively. Significant treatment differences were observed for the physical functioning scale (P = 0.024), nausea\vomiting (P = 0.001) and EQ-5D thermometer (P = 0.020) in favour of the IF treatment arm. Conclusion There was a trend in favour of IF over CF in time-to-progression. The IF group also demonstrated a better safety profile than CF and a better QL on a number of multi-item scales, suggesting that IF offers an alternative first-line platinum-free treatment option for advanced gastric cancer.