Cancer Res Treat.  2021 Oct;53(4):1096-1103. 10.4143/crt.2020.928.

Phase II Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiotherapy with Gemcitabine in Patients with Resected Pancreatic Cancer

• Lee KH
• Chie EK
• Im SA
• Kim JH
• Kwon J
• Han SW
• Oh DY
• Jang JY
• Kim JS
• Kim TY
• Bang YJ
• Kim SW
• Ha SW

• KMID: 2521584
• DOI: http://doi.org/10.4143/crt.2020.928

Abstract

Purpose
Despite curative resection, the 5-year survival for patients with resectable pancreatic cancer is less than 20%. Recurrence occurs both locally and at distant sites and effective multimodality adjuvant treatment is needed.
Materials and Methods
Patients with curatively resected stage IB-IIB pancreatic adenocarcinoma were eligible. Treatment consisted of chemotherapy with gemcitabine 1,000 mg/m² on days 1 and 8 and cisplatin 60 mg/m² on day 1 every 3 weeks for two cycles, followed by chemoradiotherapy (50.4 Gy/28 fx) with weekly gemcitabine (300 mg/m²/wk), and then gemcitabine 1,000 mg/m² on days 1 and 8 every 3 weeks for four cycles. The primary endpoint was 1-year disease-free survival rate. The secondary endpoints were disease-free survival, overall survival, and safety.
Results
Seventy-four patients were enrolled. One-year disease-free survival rate was 57.9%. Median disease-free and overall survival were 15.0 months (95% confidence interval [CI], 11.6 to 18.4) and 33.0 months (95% CI, 21.8 to 44.2), respectively. At the median follow-up of 32 months, 57 patients (77.0%) had recurrence including 11 patients whose recurrence was during the adjuvant treatment. Most of the recurrences were systemic (52 patients). Stage at the time of diagnosis (70.0% in IIA, 51.2% in IIB, p=0.006) were significantly related with 1-year disease-free survival rate. Toxicities were generally tolerable, with 53 events of grade 3 or 4 hematologic toxicity and four patients with febrile neutropenia.
Conclusion
Adjuvant gemcitabine and cisplatin chemotherapy followed by chemoradiotherapy with gemcitabine and maintenance gemcitabine showed efficacy and good tolerability in curatively resected pancreatic cancer.

Keyword

Pancreatic neoplasms; Chemoradiotherapy; Gemcitabine; Cisplatin

Figure

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  Fig. 1 Treatment scheme. CT, computed tomography; G, gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks; GP, gemcitabine 1,000 mg/m2 on days 1 and 8 and cisplatin 60 mg/m2 on day 1 repeated every 3 weeks; Weekly gemcitabine, gemcitabine 300 mg/m2 every week.

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  Fig. 2 Disposition of the patients. CCRT, concurrent chemoradiotherapy; GP, gemcitabine 1,000 mg/m2 on days 1 and 8 and cisplatin 60 mg/m2 on day 1 repeated every 3 weeks.

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  Fig. 3 Kaplan-Meier plots of disease-free survival (DFS) and overall survival (OS). (A) DFS of patients. One-year DFS rate, which was the primary endpoint, was 57.9%. Median disease-free survival was 15.0 months (95% confidence interval [CI], 11.6 to 18.4). (B) OS of patients. Median OS was 33.0 months (95% CI, 21.8 to 44.2). (C) DFS according to stage (stage IIA vs. IIB). One-year DFS rate for stage IIA and IIB was 70.0% and 51.2%, respectively (p=0.006).

Reference

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