Gemcitabine Alone Versus Gemcitabine Plus Radiotherapy in Patients With Locally Advanced Pancreatic Cancer: An Eastern Cooperative Oncology Group Trial

Abstract

A B S T R A C T PurposeThe purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer. Patients and MethodsPatients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m 2 /wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m 2 /wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m 2 for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed. ResultsOf 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n ϭ 37) or GEM plus radiation (arm B; n ϭ 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P ϭ .017 by stratified log-rank test). ConclusionThis trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.

Advances in Chemotherapy for Pancreatic Cancer

“…There is no consensus on the superiority of chemotherapy versus chemoradiotherapy from the available information, with reports of increased toxicity especially with Gemcitabine with the use of chemoradiotherapy in the reported trials. [52] Retrospective series have reported improved outcomes with median survival favouring chemoradiotherapy over chemotherapy (15 vs. 11.7 months) [53] Similar results were reported by the Eastern Cooperative Oncology Group 4,201 study [54] with Gemcitabine and chemoirradiotherapy with Gemcitabine showing chemoradiotherapy was associated with significantly improved median survival from 9.2 months in the chemotherapy alone arm to 11.1 months .…”

“…For patients with localized disease who have difficulty tolerating chemotherapy, patients experiencing symptoms from their primary tumour, or patients who may be considered for surgical exploration, consolidative chemoradiotherapy to optimize local tumour control and surgical resectability may be explored. Table 3 shows some studies of chemotherapy versus chemoradiotherapy in patients with LAPC [52,54,[56][57][58][59].…”

Gemcitabine-based Concurrent Chemoradiotherapy Versus Chemotherapy Alone in Patients with Locally Advanced Pancreatic Cancer

“…Loehrer et al also published an Eastern Cooperative Oncology Group trial named gemcitabine alone versus gemcitabine plus radiotherapy in patients with LAPC. The median survival was 9.2 months and 11.1 months for GEM alone and GEM plus radiation, respectively((one-sided P = 0.017 by stratified log-rank test), which demonstrated improved overall survival with the addition of radiation therapy to gemcitabine (Loehrer et al, 2011). We underwent 3D-CRT concurrently with gemcitabine-based chemotherapy to explore the better treatment by comparing survival time of Gem and GemRT groups.…”

Pancreatic cancer.Evidence based management guidelines of the Hungarian Pancreatic Study Group

“…Amennyiben a beteg állapota ezt nem engedi, vagy metasztázisra gyanús eltérések jelenléte igazolható, illetve a reszekálhatóság erősen kérdéses, érdemes 2-6 kemoterápiás ciklussal kezdeni. Ha a tumor a kezelés után sem operálható, fenntartó kemoterápia indokolt [33,34].…”