Acute toxicity of neoadjuvant bolus 5-FU/methotrexate and leucovorin rescue followed by continuous infusion 5-FU plus pre-operative radiation therapy for rectal cancer Journal Article
| Authors: | Minsky, B. D.; Conti, J.; Cohen, A. M.; Kelsen, D. P.; Saltz, L.; Guillem, J. G.; Paty, P. P.; Bass, J.; Bertino, J. R. |
| Article Title: | Acute toxicity of neoadjuvant bolus 5-FU/methotrexate and leucovorin rescue followed by continuous infusion 5-FU plus pre-operative radiation therapy for rectal cancer |
| Abstract: | We present an analysis of acute toxicity of 3 cycles of neoadjuvant bolus methotrexate (MTX) with leucovorin (LV) rescue plus bolus 5-FU, followed by continuous infusion 5-FU with concurrent pre-operative 5040 cGy, and post-operative bolus 5-FU/LV in patients with rectal cancer. Nine patients (1: unresectable, 6: locally advanced, 2: resectable but bulky disease) with adenocarcinoma of the rectum limited to the pelvis were enrolled. For the neoadjuvant segment, the first 4 patients received 3 successive weeks of chemotherapy followed by a 1 week break (continuous course). Due to toxicity, the remaining 5 patients received an intermittent treatment schedule consisting of 3 weekly cycles with 1 week break between cycles 1 and 2 and cycles 2 and 3 followed by a 1 week break (intermittent course). The complete response rates were clinical: 11%, pathologic: 11%, and total: 22%. The incidence of total Grade 3+ toxicity during the neoadjuvant chemotherapy segment was 56% (5/9), and during the pre-operative combined modality segment was 33% (3/9). Therefore, for the entire pre-operative period (neoadjuvant chemotherapy plus pre-operative combined modality segments) 67% (6/9) patients had grade 3+ toxicity. The incidence of total Grade 3+ toxicity during the post-operative combined modality segment was 50% (3/6). The preliminary data suggest that resectability and complete response rates with this neoadjuvant MTX/5-FU/LV plus pre-operative radiation therapy and continuous infusion 5-FU regimen are similar to our prior experience with conventional bolus 5-FU/LV and radiation therapy. However, the incidence of grade 3+ acute toxicity is higher. Additional experience is needed to determine if this approach offers a significant advantage in local control and survival. |
| Keywords: | adult; clinical article; treatment outcome; aged; clinical trial; fluorouracil; cancer combination chemotherapy; neoadjuvant therapy; methotrexate; bolus injection; phase 2 clinical trial; continuous infusion; gastrointestinal toxicity; folinic acid; phase 1 clinical trial; rectum carcinoma; intravenous drug administration; rectum resection; rectal cancer; oral drug administration; preoperative radiotherapy; human; male; female; priority journal; article; pre-operative therapy |
| Journal Title: | Radiation Oncology Investigations |
| Volume: | 4 |
| Issue: | 2 |
| ISSN: | 1065-7541 |
| Publisher: | John Wiley & Sons |
| Date Published: | 1996-01-01 |
| Start Page: | 90 |
| End Page: | 97 |
| Language: | English |
| DOI: | 10.1002/(sici)1520-6823(1996)4:2<90::aid-roi7>3.0.co;2-g |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 22 November 2017 -- Source: Scopus |
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