Phase II study of gemcitabine combined with radiation therapy in patients with localized, unresectable pancreatic cancer

Abstract

Treatment with gemcitabine concomitant with radiation therapy according to the present schedule is well tolerated and can provide prolonged CBR and disease stabilization in patients with localized, unresectable pancreatic cancer.

External Beam Radiotherapy Plus 24-Hour Continuous Infusion of Gemcitabine in Unresectable Pancreatic Carcinoma: Long-Term Results of a Phase II Study

“…Otherwise, we achieved an encouraging rate of OS, TTP, LC, and MFS compared with our previous study on 5-FUbased chemoradiation but also with other studies that used gemcitabine in association with radiation therapy (23,(25)(26)(27)(28)(29). These results are probably affected by the additional gemcitabine-based chemotherapy, which at the univariate and multivariate analysis appears to be strongly correlated to MFS and TTP.…”

“…Since gemcitabine was recognized to be more effective in terms of clinical benefit compared with 5-FU in advanced pancreatic adenocarcinoma (9), many trials experimenting gemcitabine-based CT-RT have been carried out (22)(23)(24)(25)(26)(27)(28)(29)(30). However, this combined modality seemed to be associated with concerning gastrointestinal toxicities, especially when large fields were employed (22,24).…”

Neoadjuvant Chemotherapy and Radiation for Patients with Locally Unresectable Pancreatic Adenocarcinoma: Feasibility, Efficacy, and Survival

“…[18][19][20][21][22][23] Using 5-FU combined with radiotherapy, Jessup et al 18 reported a resection rate of 13%. Kamthan et al 19 and Snady et al 22 achieved resection rates of 14 and 29%, respectively, using similar protocols of 5-FU, streptozocin, and cisplatin combined with radiotherapy with a high rate of negative pathologic margins.…”

Phase I Trial of Gemcitabine Dose Escalation with Concurrent Radiotherapy for Patients with Locally Advanced Pancreatic Cancer

“…Although several phase I and II studies have investigated gemcitabine-based CRT [11,12,13,14], a defined regimen with respect to the dose of gemcitabine or the treatment volume, fractionation, and cumulative dose of radiation has not yet been established. Regimens of conventional radiotherapy (50.4–55.8 Gy in 1.8 Gy fractions) have been given in conjunction with gemcitabine at a dose of 440–600 mg/m 2 per week [12,13]. Wolff et al [11] reported significant gastrointestinal toxicity when weekly gemcitabine was delivered at doses greater than 350 mg/m 2 with concurrent rapid administration of 30 Gy radiation in 3 Gy fractions.…”