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Phase II Study of Gemcitabine and Erlotinib as Adjuvant Therapy for Patients with Resected Pancreatic Cancer

  • Pancreatic Tumors
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

An Erratum to this article was published on 22 April 2011

Abstract

Background

There is currently no consensus about the most effective adjuvant therapy for adenocarcinoma of the pancreas. Both gemcitabine and erlotinib have been demonstrated to improve survival in patients with metastatic disease. This study was designed to evaluate the efficacy of gemcitabine and erlotinib as adjuvant therapy, and to explore potential biomarkers associated with response.

Methods

An institutional review board–approved single-center phase II trial of adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months was initiated. Primary end point was recurrence-free survival (RFS). Epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).

Results

The study completed planned accrual of 25 patients. Median follow-up was 18.2 (range 11.6–23.5) months. Recurrences were observed in 17 subjects (68%). Median RFS was 14.0 months (95% confidence interval [95% CI], 8.2–24.5) with 1-year and 2-year RFS of 56% (95% CI, 35–73) and 26% (95% CI, 6–52), respectively. Median overall survival was not reached. Estimated 1-year and 2-year overall survival was 84% (95% CI, 63–94) and 53% (95% CI, 22–76), respectively. Nine patients (36%) had a grade 3 event and only 1 (4%) had a grade 4 (neutropenia). Most toxicities were dermatologic, gastrointestinal, and constitutional. There were nonsignificant trends to longer RFS and lower recurrence rates while receiving therapy in subjects with fluorescence in situ hybridization-positive tumors and greater immunohistochemistry expression.

Conclusions

Our phase II results suggest that adjuvant gemcitabine and erlotinib is a promising regimen that merits further investigation.

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Acknowledgment

Study supported by Genentech.

Conflict of interest

The authors declare no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Surgery, Stony Brook University Hospital, Stony Brook, NY, USA

    Philip Q. Bao MD

  2. Virginia G. Piper Cancer Center, Scottsdale, AZ, USA

    Ramesh K. Ramanathan MD

  3. Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA

    Alyssa Krasinkas MD

  4. Department of Medical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA

    Nathan Bahary MD & Barry C. Lembersky MD

  5. Department of Surgery, Division of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA

    David L. Bartlett MD, Steven J. Hughes MD, Kenneth K. Lee MD, A. James Moser MD & Herbert J. Zeh III MD

Authors
  1. Philip Q. Bao MD
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  2. Ramesh K. Ramanathan MD
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  3. Alyssa Krasinkas MD
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  4. Nathan Bahary MD
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  5. Barry C. Lembersky MD
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  8. Kenneth K. Lee MD
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  10. Herbert J. Zeh III MD
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Corresponding author

Correspondence to Herbert J. Zeh III MD.

Additional information

An erratum to this article can be found at http://dx.doi.org/10.1245/s10434-011-1681-8

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Bao, P.Q., Ramanathan, R.K., Krasinkas, A. et al. Phase II Study of Gemcitabine and Erlotinib as Adjuvant Therapy for Patients with Resected Pancreatic Cancer. Ann Surg Oncol 18, 1122–1129 (2011). https://doi.org/10.1245/s10434-010-1401-9

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  • DOI: https://doi.org/10.1245/s10434-010-1401-9

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