NRG Oncology Radiation Therapy Oncology Group 0822: A phase II study of preoperative chemoradiotherapy utilizing intensity modulated radiation therapy (IMRT) in combination with capecitabine and oxaliplatin for patients with locally advanced rectal cancer
| Autor: | Hong, Theodore S., Moughan, Jennifer, Garofalo, Michael C., Bendell, Johanna, Berger, Adam C., Oldenburg, Nicklas B.E., Anne, Pramila Rani, Perera, Francisco, Lee, R. Jeffrey, Jabbour, Salma K., Nowlan, Adam, DeNittis, Albert, Crane, Christopher |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Diarrhea Male Organoplatinum Compounds Rectal Neoplasms Leucovorin Chemoradiotherapy Adjuvant Middle Aged Deoxycytidine Article Drug Administration Schedule Oxaliplatin Survival Rate Antineoplastic Combined Chemotherapy Protocols Preoperative Care Quality of Life Humans Female Fluorouracil Radiotherapy Intensity-Modulated Capecitabine Aged |
| Popis: | To evaluate the rate of gastrointestinal (GI) toxicity of neoadjuvant chemoradiation with capecitabine, oxaliplatin, and intensity modulated radiation therapy (IMRT) in cT3-4 rectal cancer.Patients with localized, nonmetastatic T3 or T4 rectal cancer12 cm from the anal verge were enrolled in a prospective, multi-institutional, single-arm study of preoperative chemoradiation. Patients received 45 Gy with IMRT in 25 fractions, followed by a 3-dimensional conformal boost of 5.4 Gy in 3 fractions with concurrent capecitabine/oxaliplatin (CAPOX). Surgery was performed 4 to 8 weeks after the completion of therapy. Patients were recommended to receive FOLFOX chemotherapy after surgery. The primary endpoint of the study was acute grade 2 to 5 GI toxicity. Seventy-one patients provided 80% probability to detect at least a 12% reduction in the specified GI toxicity with the treatment of CAPOX and IMRT, at a significance level of .10 (1-sided).Seventy-nine patients were accrued, of whom 68 were evaluable. Sixty-one patients (89.7%) had cT3 disease, and 37 (54.4%) had cN (+) disease. Postoperative chemotherapy was given to 42 of 68 patients. Fifty-eight patients had target contours drawn per protocol, 5 patients with acceptable variation, and 5 patients with unacceptable variations. Thirty-five patients (51.5%) experienced grade ≥ 2 GI toxicity, 12 patients (17.6%) experienced grade 3 or 4 diarrhea, and pCR was achieved in 10 patients (14.7%). With a median follow-up time of 3.98 years, the 4-year rate of locoregional failure was 7.4% (95% confidence interval [CI]: 1.0%-13.7%). The 4-year rates of OS and DFS were 82.9% (95% CI: 70.1%-90.6%) and 60.6% (95% CI: 47.5%-71.4%), respectively.The use of IMRT in neoadjuvant chemoradiation for rectal cancer did not reduce the rate of GI toxicity. |
| Databáze: | OpenAIRE |
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