Antitumour activity of three second-line treatment combinations in patients with metastatic colorectal cancer after optimal 5-FU regimen failure: a randomised, multicentre phase II study

Rougier, Philippe; Lepille, D.; Bennouna, Jaafar; Marre, A.; Ducreux, Michel; Mignot, L.; Hua, A.; Méry-Mignard, D.

doi:10.1093/annonc/mdf259

Cited by 79 publications

(35 citation statements)

References 33 publications

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“…Data from two other phase II trials using the irinotecan/LV5FU2 combination for heavily pretreated patients obtained ORRs of 22 and 6%, respectively [32, 33]. For the oxaliplatin/LV5FU2 combination, our results are consistent with those reported from three other phase II published studies conducted in pretreated metastatic CRC patients, with ORRs of 20, 21 and 21.2%, respectively [34,35,36]. Furthermore, compared with the other experiences based on oxaliplatin and capecitabine combination in pretreated CRC patients, our results are quite interesting and consistent with those reported from three phase II published studies, with ORRs of 15, 26 and 19%, respectively [37,38,39].…”

Section: Discussionsupporting

confidence: 89%

Continuous Infusion of Oxaliplatin plus Chronomodulated Capecitabine in 5-Fluorouracil- and Irinotecan-Resistant Advanced Colorectal Cancer Patients

Santini

Vincenzi²,

Cesa³

et al. 2005

Oncology

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Objectives: The aim of the study was to define the feasibility and efficacy of Xelox (capecitabine and oxaliplatin) administered through a new and original schedule in advanced pretreated colorectal cancer (CRC) patients. Methods: 36 metastatic CRC patients resistant at least to a previous 5-fluorouracil- and irinotecan-based chemotherapy line were included in the study. Treatment: Oxaliplatin 70 mg/m² as continuous infusion for 12 h (8.00 a.m. to 8.00 p.m.) on days 1, 8 plus chronomodulated capecitabine 1,750 mg/m²/day per os (8.00 a.m. 25% of total dose; 6.00 p.m. 25% of total dose; 11.00 p.m. 50% of total dose), on days 1–14 every 21 days. 16 (44.4%) patients had previously received only 1 chemotherapy line for metastatic disease and 20 patients (55.6%) 2 chemotherapy lines. Moreover, 12 patients (33.3%) progressed after a first or second line of oxaliplatin-based regimen as well. Results: Most frequent related G3–4 adverse reactions were diarrhea (11.6%), nausea/vomiting (8.3%), neuropathy (8.3%), mucositis (8.3%), asthenia (16.7%) and hand-foot syndrome (5.5%). G3–4 anemia, leucopenia and liver toxicities were not observed. The overall response rate was 30.6% (11/36 patients). Disease stabilization was observed in 13 patients (36.1%) and progression in 12 patients (34.3%). Between the 12 oxaliplatin-resistant patients, the overall response rate was 25% (3 patients); 6 patients (54.5%) obtained a stable disease, and only 3 patients (25%) progressed. The median overall survival was 11.3 months (95% confidence interval 7.0–15.7 months), the median response duration 2.8 months (95% confidence interval 1.2–5.6 months) and the median time to progression 6.7 months (95% confidence interval 5.7–6.3 months). The 1-year survival rate was 53.8%. Conclusions: The high overall tumor growth control, the remarkable median time to progression and overall survival and the good safety profile are of particular interest for patients with heavy pretreated metastatic CRC.

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Section: Discussionsupporting

confidence: 89%

Continuous Infusion of Oxaliplatin plus Chronomodulated Capecitabine in 5-Fluorouracil- and Irinotecan-Resistant Advanced Colorectal Cancer Patients

Santini

Vincenzi²,

Cesa³

et al. 2005

Oncology

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“…Reported response rates were 11.4 -21% (Ducreux et al, 1999;Gil-Delgado et al, 2001;Rougier et al, 2002). As shown in Table 4, results observed with regimens combining irinotecan, 5FU and LV after 5FU failure seem slightly better than those with irinotecan alone, in a cross-study comparison.…”

Section: Discussionmentioning

confidence: 85%

A phase II study of FOLFIRI-3 (double infusion of irinotecan combined with LV5FU) after FOLFOX in advanced colorectal cancer patients

et al. 2006

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In advanced colorectal cancer previously treated with oxaliplatin, efficacy of irinotecan-based chemotherapy is poor and the best regimen is not defined. We designed FOLFIRI-3 and conducted a phase II study to establish its efficacy and safety in advanced colorectal cancer patients previously treated with FOLFOX. FOLFIRI-3 consisted of irinotecan 100 mg m À2 as a 60-min infusion on day 1, running concurrently with leucovorin 200 mg m À2 as a 2-h infusion on day 1, followed by 46-h continuous infusion of 5-fluorouracil (5FU) 2000 mg m À2 , and irinotecan 100 mg m À2 repeated on day 3, at the end of the 5FU infusion, every 2 weeks. Sixty-five patients entered the study. The intent-to-treat objective response rate was 23% (95% CI 13 -33%). Disease was stable in 37% of patients, progressed in 26% and was not assessable in 14%. From the start of FOLFIRI-3, median progression-free survival was 4.7 months and median survival 10.5 months. Main toxicities (% of patients) were grade 3 -4 diarrhoea 23% and grade 4 neutropenia 11%. FOLFIRI-3 is a promising regimen achieving high response rate and progression-free survival in patients previously treated with FOLFOX with a moderate toxicity.

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“…По дан-ным авторов, удалось добиться следующих показате-лей общей выживаемости: 12,2 мес в группе FOLFIRI, 11,5 мес в группе FOLFOX и 11 мес в группе IROX. Токсичность лечения III-IV степени отмечена у 33 % па-циентов первых 2 групп и у 39 % в группе IROX [44].…”

Section: особенности метаболизмаunclassified

Irinotecan in the treatment of colorectal cancer. A literature review

Иванов¹,

Гордеев²,

Байчоров³

et al. 2017

Onkol. koloproktol.

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Antitumour activity of three second-line treatment combinations in patients with metastatic colorectal cancer after optimal 5-FU regimen failure: a randomised, multicentre phase II study

Abstract: Thus, second-line treatment with irinotecan/LV5FU2, oxaliplatin/LV5FU2 or irinotecan/oxaliplatin, provides good tumour growth control and survival coupled with an acceptable safety profile.

Cited by 79 publications

References 33 publications

Continuous Infusion of Oxaliplatin plus Chronomodulated Capecitabine in 5-Fluorouracil- and Irinotecan-Resistant Advanced Colorectal Cancer Patients

Continuous Infusion of Oxaliplatin plus Chronomodulated Capecitabine in 5-Fluorouracil- and Irinotecan-Resistant Advanced Colorectal Cancer Patients

A phase II study of FOLFIRI-3 (double infusion of irinotecan combined with LV5FU) after FOLFOX in advanced colorectal cancer patients

Irinotecan in the treatment of colorectal cancer. A literature review

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