Randomised, non-comparative phase II study of weekly docetaxel with cisplatin and 5-fluorouracil or with capecitabine in oesophagogastric cancer: the AGITG ATTAX trial

Abstract

BACKGROUND: Docetaxel administered 3-weekly with cisplatin and 5-fluorouracil leads to better survival than does standard therapy in patients with oesophagogastric cancer, but leads to high rates of haematological toxicity. Weekly docetaxel is associated with less haematological toxicity. This randomised phase II study tested weekly docetaxel-based combination chemotherapy regimens, with the aim of maintaining their activity while reducing toxicity. METHODS: Patients with histologically confirmed metastatic oesophageal or gastric carcinoma were randomised to receive weekly docetaxel (30 mg m À2 ) on days 1 and 8, cisplatin (60 mg m À2 ) on day 1, and 5-fluorouracil (200 mg m À2 per day) continuously, every 3 weeks (weekly TCF, wTCF); or docetaxel (30 mg m À2 ) on days 1 and 8 and capecitabine (1600 mg m À2 per day) on days 1 -14, every 3 weeks (weekly TX, wTX). RESULTS: A total of 106 patients were enrolled (wTCF, n ¼ 50; wTX, n ¼ 56). Response rates, the primary end point, were 47% with wTCF and 26% with wTX. Rates of febrile neutropenia were low in each arm. Median progression-free and overall survival times were 5.9 and 11.2 months for wTCF and 4.6 and 10.1 months for wTX, respectively. CONCLUSION: Weekly TCF and TX have encouraging activity and less haematological toxicity than TCF administered 3-weekly. Weekly docetaxel-based combination regimens warrant further evaluation in this disease.

QLU-C10D: a health state classification system for a multi-attribute utility measure based on the EORTC QLQ-C30

“…Eighteen suitable datasets were obtained [27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44]. Table 1 summarises their characteristics and the number of observations each contributed to various psychometric analyses.…”

Optimal chemotherapy for advanced gastric cancer: is there a global consensus?

“…Although evidence from phase III studies is lacking, the modification of DCF by alternative scheduling has decreased the toxicity, apparently without compromising the efficacy. Therefore, if docetaxel-based first-line treatment is considered, one should refrain from using classic DCF and choose an alternative treatment protocol such as Gastro-Tax [42], FLOT [43], or ATTAX [44]. Regarding the use of an intensive docetaxel-based triplet combination in elderly patients (C65 years), the FLOT combination appears to be feasible and effective but no better than FOLFOX, although toxicity was markedly increased and quality of life was negatively impacted in a significant proportion of patients during the first 8 weeks of treatment [45].…”

Biweekly docetaxel, fluorouracil, leucovorin, oxaliplatin (TEF) as first-line treatment for advanced gastric cancer and adenocarcinoma of the gastroesophageal junction: safety and efficacy in a multicenter cohort

“…Weekly administration decreased the rate of hematological toxicity, with only 4 % of grade 3-4 neutropenia [16]. However, nonhematologic toxicities were frequent with this regimen, with 23 % of patients hospitalized for non-hematologic toxicity in this retrospective study by Overman et al In a phase II trial reported by Tebbut et al [17], with weekly mDCF there was a high rate of grade 3-4 gastrointestinal toxicity (diarrhea 22 %, stomatitis 18 %, nausea 16 %, asthenia 18 %) as reported earlier by Lorenzen et al [18], who noted a similar toxicity profile.…”