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Clinical Trial
. 2010 Dec;119(3):451-6.
doi: 10.1016/j.ygyno.2010.08.008. Epub 2010 Sep 15.

Erlotinib added to carboplatin and paclitaxel as first-line treatment of ovarian cancer: a phase II study based on surgical reassessment

Stephanie V Blank  1 , Paul Christos, John P Curtin, Noah Goldman, Carolyn D Runowicz, Joseph A Sparano, Leonard Liebes, Helen X Chen, Franco M Muggia
Affiliations
Clinical Trial

Erlotinib added to carboplatin and paclitaxel as first-line treatment of ovarian cancer: a phase II study based on surgical reassessment

Stephanie V Blank et al. Gynecol Oncol. 2010 Dec.

Abstract

Background: The purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal cancers (OFPC).

Methods: Patients with stage III-IV OFPC initiated treatment within 12 weeks of initial cytoreductive surgery or, after histologic confirmation of diagnosis, neoadjuvantly. Treatment included paclitaxel (175 mg/m²) and carboplatin (AUC 6) every 3 weeks for up to 6 cycles, plus oral erlotinib 150 mg daily. The primary objective was to determine whether the pCR rate at reassessment surgery was at least 60% after optimal cytoreduction at initial surgery (< 1cm residual disease), or at least 40% after suboptimal cytoreduction (at least 1cm residual disease) using a two-stage design (alpha=0.10, beta=0.10).

Results: The study population included 56 patients with stage III-IV OFPC. EGFR gene amplification was present in 15% of the 20 tumors evaluated. Twenty-eight patients had protocol therapy after optimal cytoreduction (stratum I), 23 had protocol therapy either after suboptimal cytoreduction (stratum II), and 5 received neoadjuvant therapy prior to cytoreduction (stratum III). Pathologic CR was confirmed in 8 patients (29%; 95% confidence intervals 13%, 49%) in stratum I and 3 patients (11%, 95% C.I. 2%, 28%) in stratum II, which did not meet the prespecified efficacy endpoint in either stratum.

Conclusions: Among unselected patients, erlotinib plus carboplatin-paclitaxel did not improve pCR rates compared with historical experience with carboplatin-paclitaxel alone in patients with stage III-IV OFPC.

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Figures

Figure 1a-b
Figure 1a-b
Progression-free survival (1a) and overall survival (1b) in 51 patients treated with erlotinib plus carboplatin/paclitaxel prior to surgery.
Figure 1a-b
Figure 1a-b
Progression-free survival (1a) and overall survival (1b) in 51 patients treated with erlotinib plus carboplatin/paclitaxel prior to surgery.
Figure 2a-b
Figure 2a-b
Progression-free survival (2a) and overall survival (2b) in 51 patients treated with erlotinib plus carboplatin/paclitaxel prior to surgery by treatment stratum.
Figure 2a-b
Figure 2a-b
Progression-free survival (2a) and overall survival (2b) in 51 patients treated with erlotinib plus carboplatin/paclitaxel prior to surgery by treatment stratum.
See this image and copyright information in PMC

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