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Clin Colorectal Cancer. 2018 Mar;17(1):e121-e125. doi: 10.1016/j.clcc.2017.10.008. Epub 2017 Oct 24.

Cetuximab Combined With Induction Oxaliplatin and Capecitabine, Followed by Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer: SWOG 0713.

Author information

1
Division of Medical Oncology, New York University, New York, NY. Electronic address: leichman1@cox.net.
2
SWOG Statistics and Data Management Center, Seattle, WA.
3
Radiation Oncology Center of Olathe, Olathe, KS.
4
Division of Surgical Oncology, Oregon Health & Science University, Portland, OR.
5
Division of Medical Oncology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
6
Southeast Cancer Control Consortium-Upstate NCORP/Lowcountry Hematology Oncology, Mt Pleasant, SC.
7
Department of Medicine, Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY.
8
Heartland NCORP/Cancer Care Specialists of Central Illinois, Decatur, IL.
9
SWOG Group Chair's Office/Oregon Health & Science University, Portland, OR.
10
Department of Oncology, Yale University, New Haven, CT.

Abstract

BACKGROUND:

Neoadjuvant chemoradiation (NCRT) is standard treatment for locally advanced rectal cancer. Pathologic complete response (pCR) has associated with improved survival. In modern phase III trials of NCRT, pCR ranges from 10% to 20%. Cetuximab improves response in KRAS (KRAS proto-oncogene) wild type (wt) metastatic colorectal cancer. S0713 was designed to assess improvement in pCR with additional use of cetuximab with induction chemotherapy and NCRT for locally advanced, KRAS-wt rectal cancer.

PATIENTS AND METHODS:

Patient eligibility: stage II to III biopsy-proven, KRAS-wt rectal adenocarcinoma; no bowel obstruction; adequate hematologic, hepatic and renal function; performance status of 0 to 2. Target enrollment: 80 patients.

TREATMENT:

induction chemotherapy with wCAPOX (weekly capecitabine and oxaliplatin) and cetuximab followed by the same regimen concurrent with radiation (omitting day 15 oxaliplatin). If fewer than 7 pCRs were observed at planned interim analysis after 40 patients received all therapy, the study would close. Eighty eligible patients would provide 90% power given a true pCR rate > 35% at a significance of 0.04. The regimen would lack future interest if pCR probability was ≤ 20%.

RESULTS:

Between February 2009 and April 2013, 83 patients registered. Four were ineligible and 4 not treated, leaving 75 evaluable for clinical outcomes and toxicity, of whom 65 had surgery. Of 75 patients, 20 had pCR (27%; 95% confidence interval [CI], 17%-38%); 19 (25%) had microscopic cancer; 36 (48%) had minor/no response (including 10 without surgery). Three-year disease-free survival was 73% (95% CI, 63%-83%).

CONCLUSION:

Our trial did not meet the pCR target of 35%. Toxicity was generally acceptable. This regimen cannot be recommended outside the clinical trial setting.

KEYWORDS:

Chemotherapy; Cooperative group trial; KRAS; Phase II; pCR

PMID:
29233486
DOI:
10.1016/j.clcc.2017.10.008

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