☆ 4.5 Article

A phase I radiation dose-escalation study to determine the maximal dose of radiotherapy in combination with weekly gemcitabine in patients with locally advanced pancreatic adenocarcinoma

RADIATION ONCOLOGY (2008)

期刊

RADIATION ONCOLOGY

卷 3, 期 -, 页码 -

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BMC

DOI: 10.1186/1748-717X-3-30

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Oncology Radiology, Nuclear Medicine & Medical Imaging

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Eli Lilly Benelux NV

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摘要

Background: The primary objective of this study was to determine the maximum tolerated dose (MTD) of escalating doses of radiotherapy (RT) concomitantly with a fixed dose of gemcitabine (300 mg/m(2)/week) within the same overall treatment time. Methods: Thirteen patients were included. Gemcitabine 300 mg/m(2)/week was administered prior to RT. The initial dose of RT was 45 Gy in 1.8 Gy fractions, escalated by adding 5 fractions of 1.8 Gy (one/week) to a dose of 54 Gy with a total duration kept at 5 weeks. All patients received a dynamic MRI to assess the pancreatic respiratory related movements. Toxicity was scored using the RTOG-EORTC toxicity criteria. Results: Three of six patients experienced an acute dose limiting toxicity (DLT) at the 54 Gy dose level. For these patients a grade III gastro-intestinal toxicity (GI) was noted. Patients treated at the 45 Gy dose level tolerated therapy without DLT. The 54 Gy dose level was designated as the MTD and was deemed not suitable for further investigation. Between both dose levels, there was a significant difference in percentage weight loss (p = 0.006) and also in cumulative GI toxicity (p = 0.027). There was no grade 3 toxicity in the 45 Gy cohort versus 4 grade 3 toxicity events in the 54 Gy cohort. The mean dose to the duodenum was significantly higher in the 54 Gy cohort (38.45 Gy vs. 51.82 Gy; p = 0.001). Conclusion: Accelerated dose escalation to a total dose of 54 Gy with 300 mg/m(2)/week gemcitabine was not feasible. GI toxicity was the DLT. Retrospectively, the dose escalation of 9 Gy by accelerated radiotherapy might have been to large. A dose of 45 Gy is recommended. Considering the good patient outcomes, there might be a role for the investigation of a fixed dose of gemcitabine and concurrent RT with small fractions (1.8 Gy/day) in borderline resectable or unresectable non-metastatic locally advanced pancreatic cancer.

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Nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy versus nab-paclitaxel and gemcitabine alone for locally advanced pancreatic adenocarcinoma: a prospective cohort study

Shuling Chen, Jiaxin Li, Aoran Dong, Zelong Liu, Meiyan Zhu, Meng Jin, Guangyan Wei, Shuang Wu, Yan Wang, Yong Chen, Zhenwei Peng

Summary: This study compared the efficacy and safety of combination therapy with immunotherapy and radiotherapy versus chemotherapy alone for patients with locally advanced pancreatic adenocarcinoma (LAPC). The combination treatment group showed significant advantages in median overall survival and progression-free survival compared to the chemotherapy alone group. However, the incidence of severe adverse events did not differ significantly between the two groups. Therefore, combination therapy appears to be an effective and safe treatment option for LAPC patients.

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