Special Session

SS 22 - Late-Breaking Abstracts Special Session

LBA8 - Preoperative Chemoradiotherapy Potentially Improves Outcome for (borderline) Resectable Pancreatic Cancer: Preliminary Results of the Dutch Randomized Phase III Preopanc Trial

Tuesday, October 23
8:25 AM - 8:35 AM
Location: Room 007 C/D

Preoperative Chemoradiotherapy Potentially Improves Outcome for (borderline) Resectable Pancreatic Cancer: Preliminary Results of the Dutch Randomized Phase III Preopanc Trial
E. Versteijne1, M. Suker2, C. J. A. Punt1, K. B. Groothuis3, J. C. Beukema4, A. Bruynzeel5, J. Buijsen6, E. M. Hendriksen7, M. P. W. Intven8, K. Neelis9, J. Nuyttens2, G. M. R. Paardekooper10, T. Rozema11, H. Rütten12, M. J. T. van Der Sangen13, A. H. Zwinderman1, C. H. J. van Eijck2, and G. van Tienhoven1; 1Amsterdam UMC, Univ of Amsterdam, Amsterdam, Netherlands, 2Erasmus MC Cancer Institute, Rotterdam, Netherlands, 3Netherlands Comprehensive Cancer Organisation (IKNL), Nijmegen, Netherlands, 4University Medical Center Groningen, Groningen, Netherlands, 5Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands, 6MAASTRO Clinic, Maastricht, Netherlands, 7Medisch centrum Twente, Enschede, Netherlands, 8University Medical Center Utrecht, Utrecht, Netherlands, 9Leiden University Medical Center, Leiden, Netherlands, 10Isala Clinics, Zwolle, Netherlands, 11Instituut Verbeeten, Tilburg, Netherlands, 12Radboud University Medical Center, Nijmegen, Netherlands, 13Catharina Hospital, Eindhoven, Netherlands

Purpose/Objective(s): For patients with (borderline) resectable pancreatic adenocarcinoma standard treatment is resection followed by adjuvant chemotherapy. Previous studies suggest a benefit of preoperative treatment. The aim of this multicenter phase III, superiority, randomized controlled trial is to test the hypothesis that median overall survival of patients with (borderline) resectable pancreatic cancer improves with preoperative chemoradiotherapy.

Materials/Methods: Patients with pathologically confirmed (borderline) resectable pancreatic cancer > 2 cm were randomized between immediate surgery (arm A) and preoperative chemoradiotherapy (arm B), both followed by adjuvant chemotherapy. After diagnostic laparoscopy, the preoperative chemoradiotherapy consisted of 15 daily fractions of 2.4 Gray combined with gemcitabine, 1,000 mg/m2 on days 1, 8 and 15, preceded and followed by modified courses of gemcitabine. The adjuvant chemotherapy consisted of 6 cycles of gemcitabine in arm A versus 4 cycles in arm B. Primary endpoint was overall survival (OS) by intention to treat, secondary endpoints were (R0) resection rate, disease free survival (DFS), distant metastases free interval (DMFI), locoregional recurrence free interval (LRFI) and toxicity. Accrual took place between April 23, 2013 and July 25, 2017.

Results: In total, 246 patients were included in the intention-to-treat analysis (127 patients in arm A and 119 in arm B). At this analysis, 149 of the 176 required events for the primary outcome were observed. The primary outcome OS was not significantly improved in arm B (median 13.5 vs. 17.1 months; HR 0.74; p=0.074). In arm A, 120/127 patients underwent an exploratory laparotomy, versus 81/119 in arm B. The most common reason not having exploratory laparotomy in arm B was metastatic disease found at laparoscopy or progression during the preoperative treatment. Resection rates were 72% (91/127) in arm A vs. 61% (72/119) in arm B (p= 0.087). However, there was improvement in R0 resection rate (31% vs. 63%, p=<0.001), DFS (median 7.9 vs. 9.9 months; HR 0.71; p=0.023), DMFI (median 10.6 vs 18.4 months; HR 0.64; p=0.013) and LRFI (median 11.8 vs not reached; HR 0.55; p<0.001) after preoperative treatment (arm B). No significant difference was observed in adverse events between both groups (p= 0.28). A subgroup analysis of patients who actually underwent a resection and started adjuvant gemcitabine (61/127 (48%) in arm A and 55/119 (46%) in arm B) was performed which showed a median OS of 19.1 in arm A, compared to 42.1 months in arm B (p<0.001).

Conclusion: Our preliminary data suggest a benefit in outcome of preoperative chemoradiotherapy in (borderline) resectable pancreatic cancer compared to immediate surgery. The final analysis is expected within half a year.

Author Disclosure: E. Versteijne: None. M. Suker: None. C.J. Punt: None. K.B. Groothuis: None. J.C. Beukema: None. J. Buijsen: None. E.M. Hendriksen: None. M.P. Intven: None. M.J. van Der Sangen: One time speaker fee; Roche Netherlands. Board Member; BOOG. A.H. Zwinderman: None. C.H. van Eijck: None. G. van Tienhoven: None.

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LBA8 - Preoperative Chemoradiotherapy Potentially Improves Outcome for (borderline) Resectable Pancreatic Cancer: Preliminary Results of the Dutch Randomized Phase III Preopanc Trial



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