Fortnightly or fractionated weekly docetaxel-cisplatin-5-FU as first-line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study.

BACKGROUND: While docetaxel/cisplatin/5-fluorouracil (DCF) outperforms CF in first-line gastric adenocarcinoma, toxicity remains an issue. METHODS: This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m2 , C 35 mg/m², F 1800 mg/m² over 24 h, on days 1 and 8 every 3 weeks, arm (1) or fortnightly DCF (D 50 mg/m2 , C 50 mg/m², F 2000 mg/m² over 48 h every 2 weeks, arm (2). Prophylactic granulocyte colony-stimulating factor (G-CSF) was not allowed. The primary endpoint was the rate of febrile neutropenia within the first six treatment weeks (early FN). RESULTS: A total of 106 eligible patients were recruited. The early and overall FN rates were 9.5% and 17% in arm 1, respectively, and 5.9% and 8% in arm 2, respectively. Grade ≥3 toxicities occurred in 81% of patients in arm 1 and 90% of patients in arm 2, the most common being neutropenia (33% vs. 61%), fatigue (27% vs. 25%), vomiting (21% vs. 12%), anorexia (19% vs. 18%), and diarrhea (17% vs. 10%). Median progression-free survival and overall survival were 5.1 (95% CI, 3.2-6.5) and 8.2 months (95% CI, 6.0-14.5), respectively, in arm 1 and 5.2 (95% CI, 3.0-6.9) and 11.9 months (95% CI, 7.4-15.9), respectively, in arm 2. CONCLUSIONS: Fractionated weekly and fortnightly DCF regimens are associated with a low risk of early FN, and a better hematological toxicity profile as compared to historical DCF without compromising efficacy. Both regimens offer greater convenience removing the need for systematic use of prophylactic G-CSF.

Relevance of Geriatric Assessment in Older Patients With Colorectal Cancer.

INTRODUCTION: This study aims to evaluate the relevance of geriatric assessment (GA) in older patients with colorectal cancer (CRC) and to study functional status (FS) and chemotherapy-related toxicity during treatment. METHODS: Patients with CRC aged ≥ 70 years were evaluated at baseline using a GA. Results were communicated to the treating physician. At 2 to 3 months follow-up, FS was reassessed, and chemotherapy-related toxicity was recorded. RESULTS: A total of 193 patients, with a median age of 77 years, were included. GA was abnormal in 75% and revealed unknown problems in 40%. Treatment was altered in 37% based on clinical assessment. GA led to geriatric interventions in 9 patients (5%) and additionally influenced treatment in 1 patient. At follow-up (n = 164), functional decline was observed in 29 patients (18%) for activities of daily living (ADL) and in 60 patients (37%) for instrumental activities of daily living (IADL). Baseline IADL, depression, fatigue, and cognition were predictors for ADL decline, whereas no predictors for IADL decline could be identified. In the 109 patients receiving chemotherapy, stage and baseline fatigue were predictive for grade 3/4 hematologic toxicity, and baseline ADL, fatigue, and nutrition were predictive for grade 3/4 nonhematologic toxicity. CONCLUSION: Although GA identified previously unknown problems in more than one-third of older CRC patients, the impact on interventions or treatment decisions was limited. Baseline GA parameters may predict functional decline and chemotherapy-related toxicity. Education of physicians treating older patients with CRC is an essential step in the implementation of GA and subsequent interventions.