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| Title: | A novel 5-FU-oxaliplatin based chemoradiation schema for stage II and III rectal carcinoma: updated results from a phase II study |
| Author(s): | E. M. Rishe, S. Malamud, K. Hu, W. Enker, P. Kozuch, R. Blum, J. Martz, M. Bernstein, M. Grossbard, S. Gettinger, I. Shapira |
| Lay Summary: | This abstract reflects the continuum cancer centers of New York multi-specialty expertise in delivering the most innovative treatment for rectal cancer available. Experts in radiation oncology, medical oncology, gastroenterology, diagnostic radiology and colorectal surgery have teamed to develop a novel chemotherapy regimen in combination with radiation therapy followed by surgery for patients with rectal cancer. This early update of our work shows the tolerability and efficacy of this unique regimen. Notably, the vast majority of patients have been able to complete all aspects of this therapy with minimal side effects and the pathological complete response rate and down staging has compared favorably with current state of the art care. |
| Background: | 5-FU based neoadjuvant chemoradiation (CRT) is the standard of care for stage 2 and 3 rectal cancer(ca). Pathologic complete responses(pCR) and downstaging have been associated with improved survival outcomes. The addition of oxaliplatin or irinotecan to neoadjuvant treatment has led to improved pCR and down staging. The feasibility and efficacy of “total” oxaliplatin therapy (pre and postop oxaliplatin) for stage 2 and 3 rectal ca patients has yet to be defined. |
| Objective: | To determine the feasibility, toxicity and efficacy of neoadjuvant oxaliplatin, 5-FU and RT followed by surgery, with postop adjuvant modified FOLFOX6. |
| Methods: | Single institution, single arm phase II trial of oxaliplatin 60mg/m2 weekly for 6 weeks with continuous infusion 5-FU 225 mg/m2/d1-5. Postoperative therapy consisted of mFOLFOX6 every 2 weeks for 6 cycles. Eligibility included previously untreated, histologically proven rectal cancer, T3-4N0M0 or TanyN+M0 (stage II-III). |
| Results: | 22 pts have been enrolled in this study with a mean follow up of 23 months, median 11 months. One died of disease prior to CRT. 13 pts have completed total oxaliplatin therapy. Prior to adjuvant therapy 2 pts dropped out: 1 from pulmonary symptoms and 1 due to asthenia. 16 pts completed neoadjuvant therapy and went on to total mesorectal excision. 3 pts attained a pCR and 13 attained downstaging. Significant toxicity has been limited to grade 3 neuropathy in 2 pts (both completely resolved), one grade 3 GI toxicity (self limited) and two grade 3 oxaliplatin hypersensitivity reactions leading to drug discontinuation during radiation therapy. 88% of intended neoadjuvant oxaliplatin dose and for those who had planned surgery, 87% of intended adjuvant oxaliplatin was delivered. |
| Conclusions: | This updated analysis shows the feasibility of pre and post operative oxaliplatin based therapy as a multimodality approach to rectal cancer. Albeit small, our data set demonstrates encouraging pCR and tumor downstaging rates with acceptable toxicity outcomes. |
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