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Chemoradiotherapy (Gemox Plus Helical Tomotherapy) for Unresectable Locally Advanced Pancreatic Cancer: A Phase II Study

1
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli n. 40, 47014 Meldola, Italy
2
Unit of Biostatistics and Clinical Trials, IRST-IRCCS, Via P. Maroncelli n. 40, 47014 Meldola, Italy
3
Radiotherapy Unit, IRST-IRCCS, Via P. Maroncelli n. 40, 47014 Meldola, Italy
4
General and Oncologic Surgery Unit, Morgagni-Pierantoni Hospital, AUSL Romagna, Via C. Forlanini n. 34, 47121 Forlì Italy
5
Department of Medical and Surgical Sciences, University of Bologna, Via Massarenti n. 9, 40138 Bologna, Italy
6
Radiology Unit, IRST IRCCS, Via P. Maroncelli n. 40, 47014 Meldola, Italy
*
Author to whom correspondence should be addressed.
Cancers 2019, 11(5), 663; https://doi.org/10.3390/cancers11050663
Received: 16 April 2019 / Revised: 9 May 2019 / Accepted: 10 May 2019 / Published: 13 May 2019
(This article belongs to the Special Issue Advances in Pancreatic Cancer Research)
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Abstract

The aim of the study was to evaluate the safety and efficacy of a new chemo-radiotherapy regimen for patients with locally advanced pancreatic cancer (LAPC). Patients were treated as follows: gemcitabine 1000 mg/m2 on day 1, and oxaliplatin 100 mg/m2 on day 2, every two weeks (GEMOX regimen) for 4 cycles, 15 days off, hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days), 15 days off, 4 additional cycles of GEMOX, restaging. From April 2011 to August 2016, a total of 42 patients with non resectable LAPC were enrolled. Median age was 67 years (range 41–75). Radiotherapy was well tolerated and the most frequently encountered adverse events were mild to moderate nausea and vomiting, abdominal pain and fatigue. In total, 9 patients underwent surgical laparotomy (5 radical pancreatic resection 1 thermoablation and 3 explorative laparotomy), 1 patient became operable but refused surgery. The overall resectability rate was 25%, while the R0 resection rate was 12.5%. At a median follow-up of 50 months, the median progression-free survival and overall survival were 9.3 (95% CI 6.2–14.9) and 15.8 (95% CI 8.2–23.4) months, respectively. The results demonstrate the feasibility of a new chemo-radiotherapy regimen as a potential treatment for unresectable LAPC. View Full-Text
Keywords: pancreatic cancer; neoadjuvant therapy; GEMOX; radiotherapy pancreatic cancer; neoadjuvant therapy; GEMOX; radiotherapy
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Passardi, A.; Scarpi, E.; Neri, E.; Parisi, E.; Ghigi, G.; Ercolani, G.; Gardini, A.; La Barba, G.; Pagan, F.; Casadei-Gardini, A.; Valgiusti, M.; Ferroni, F.; Frassineti, G.L.; Romeo, A. Chemoradiotherapy (Gemox Plus Helical Tomotherapy) for Unresectable Locally Advanced Pancreatic Cancer: A Phase II Study. Cancers 2019, 11, 663.

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