Safety and efficacy of biweekly gemcitabine in combination with capecitabine (GemCap) in elderly and frail patients (pts) with resected pancreatic cancer (PC)

Autor: Nausheen Hakim, Antonia Maloney, Jyothi Jose, Linda Moriarty, Wasif M. Saif, Jeffrey Chi, Danielle K. DePeralta, Gary B. Deutsch, Melissa H Smith, Sandeep Anantha, Arvind Rishi, Hasan Rehman, Elliot Newman, Gene F. Coppa, William Nealon
Rok vydání: 2020
Předmět:
Zdroj: Journal of Clinical Oncology. 38:4628-4628
ISSN: 1527-7755
0732-183X
Popis: 4628 Background: ESPAC-4 study showed that GemCap conferred a survival benefit over gemcitabine monotherapy in resected PC patients. ESPAC-4 included patients with median age of 65 years (37-81) and ECOG performance status (PS) of 0 (43%), 1 (54%) and 2 (2%) who received a median cumulative dose of gemcitabine of 15,000 mg/m2, capecitabine. Here we present our experience with an adopted biweekly regimen of GemCap in patients who were ≥ 75 years and those who were deemed not suitable for ESPAC-4 regimen. Methods: Patients ≥ 75 years with resected PC, ECOG PS of 0-2 and no prior treatments were included. Patients were treated with a modified regimen of gemcitabine (1000-2000 mg/m2) every 2 weeks and capecitabine (800-1000 mg/m2) day 1-7 every 2 weeks. Patients were evaluated for progression-free survival (PFS), overall survival (OS) and sites of recurrence. Toxicities were graded according to NCI CTCAE v5.0. Results: Thirty-five (22M, 13F) patients, ≥ 75 (median age 79) treated with biweekly Gem-Cap adjuvant treatment. 7 (28%) patients had ECOG PS of 1 and 28 (72%) had ECOG PS of 2. There were 5, 7 and 16 patients with stage I, II and III disease. Nine patients (25%) had R1 and 26 (75%) had R0 resection. The median PFS and OS were 8.0 months and 22.0 months. Nine (25%) had local recurrence, 21 (60%) had metastatic disease and 3 (8.6%) had NED. Two patients were lost to follow-up. The most frequent toxicities were grades 1-2 anemia (20%), thrombocytopenia (8%) and hand-foot syndrome (HFS) (10%). Grade ≥3 included diarrhea (4%) and HFS (1%) with no treatment-related discontinuations. Treatment compliance was 100%. Delays were necessary in 7% of cases and dose reduction was required in 4% of cases. There was no treatment related death. Conclusions: This schedule of biweekly GemCap regimen suggests an acceptable option in for elderly, frail patients with PC and warrants further exploration in patients not suitable for FOLFIRINOX, full dose GemCap or a clinical trial. This regimen required fewer dose reduction, omission or delays and allowed to administer pegylated-filgrastim. Previous studies have also shown decreased toxicity and equal efficacy of 7/7 schedule of capecitabine. Moreover, fewer visits to oncology and related expense do favor towards benefit. Additionally, this tolerable regimen is ideal to be combined with immunotherapy in clinical trials for this patient population.
Databáze: OpenAIRE
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