S-1 (Teysuno) and gemcitabine in Caucasian patients with unresectable pancreatic adenocarcinoma.

Autor: Winther SB; Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark. stine.winther@rsyd.dk.; Department of Clinical Research, University of Southern Denmark, Winsløwparken 19, 3. Sal, 5000, Odense C, Denmark. stine.winther@rsyd.dk., Bjerregaard JK; Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark., Schonnemann KR; Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark., Ejlsmark MW; Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark., Krogh M; Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark., Jensen HA; Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark., Pfeiffer P; Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark.; Department of Clinical Research, University of Southern Denmark, Winsløwparken 19, 3. Sal, 5000, Odense C, Denmark.; Odense Pancreas Center (OPAC), Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark.
Jazyk: angličtina
Zdroj: Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2018 Mar; Vol. 81 (3), pp. 573-578. Date of Electronic Publication: 2018 Jan 31.
DOI: 10.1007/s00280-018-3528-5
Abstrakt: Purpose: Gemcitabine has been standard of care in advanced pancreatic adenocarcinomas (PC) for almost two decades. Randomized, primarily Japanese, studies have shown promising efficacy when combined with S-1 (GemS-1); however, no data are published in Caucasian patients. We report the first study with a combination of GemS-1 in an unselected cohort of Caucasian PC patients.
Methods: In this observational cohort study, we analyzed efficacy and toxicity prospectively.
Results: From July 2012 to July 2014, 64 patients received at least one cycle of GemS-1. 16 patients started therapy with gemcitabine and capecitabine (GemCap) but switched to GemS-1 after median 3 cycles of GemCap due to toxicity (hand-foot syndrome). 48 patients received GemS-1 as initial therapy. For the complete cohort, median age was 68 years (range 44-80); 22 patients (34%) had locally advanced PC; 42 patients (66%) had metastatic disease. Five patients had received prior adjuvant therapy with gemcitabine and 9 pts had received prior first-line therapy. The most common adverse event was fatigue (86%), however, only grade 3 in 3%. Five patients (8%) developed febrile neutropenia. Median PFS was 8.1 (95% CI 6.9-9.0) months and median OS was 11.7 (95% CI 10.7-13.1) months in the whole GemS-1 population. In the 48 patients starting with GemS-1, median PFS was 7.7 (95% CI 6.7-8.9) months and median OS was 11.5 (95% CI 9.7-12.3) months.
Conclusions: The combination of gemcitabine and S-1 is safe and associated with promising efficacy in a Caucasian population; however, this needs to be confirmed in prospective clinical trials.
Databáze: MEDLINE