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Multicenter phase II study of FOLFIRI plus bevacizumab after discontinuation of oxaliplatin-based regimen for advanced or recurrent colorectal cancer (CR0802).

Suenaga M, Nishina T, Mizunuma N, Yasui H, Ura T, Denda T, Ikeda J, Esaki T, Nishisaki H, Takano Y, Sugiyama Y, Muro K - BMC Cancer (2015)

Bottom Line: The incidence of grade 3 or higher adverse events was 60.2% for neutropenia, 23.7% for leukopenia, 9.7% for diarrhea, 6.5% for anorexia, and 5.4% for fatigue.All these adverse events and other adverse events were controllable.UMIN000001817 .

View Article: PubMed Central - PubMed

Affiliation: Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan. m.suenaga@jfcr.or.jp.

ABSTRACT

Background: To investigate the efficacy and safety of FOLFIRI plus bevacizumab regimen with irinotecan (180 mg/m(2)) in patients with advanced or recurrent colorectal cancer who were of the wild-type or heterozygous group for UGT1A1*28 and *6 polymorphisms and discontinued to oxaliplatin-based regimen, prospectively.

Methods: The study population consisted of patients who had discontinued oxaliplatin-based regimen for any reason. The primary endpoint was the response rate. FOLFIRI and bevacizumab regimen [irinotecan: 180 mg/m(2), 5-fluorouracil infusion: 2400 mg/m(2), 5-fluorouracil bolus: 400 mg/m(2), levofolinate calcium: 200 mg/m(2), bevacizumab: 5 mg/kg] was repeated every 2 weeks for up to 24 cycles.

Results: Ninety-four patients were enrolled; 93 patients were evaluated on safety, 94 patients on efficacy. The response rate was 10.1% (95% confidence interval (CI): 4.7-18.3%). The median time to treatment failure, progression-free survival, and overall survival were 4.1 months (95% CI: 2.8-4.8 months), 5.4 months (95% CI: 4.1-6.2 months), and 14.5 months (95% CI: 11.8-17.0 months), respectively. The treatment-related death was 1.1%, and the early death ≤30 days after the last study treatment was 1.1%. The incidence of grade 3 or higher adverse events was 60.2% for neutropenia, 23.7% for leukopenia, 9.7% for diarrhea, 6.5% for anorexia, and 5.4% for fatigue. All these adverse events and other adverse events were controllable.

Conclusions: FOLFIRI plus bevacizumab regimen with an initial irinotecan dose of 180 mg/m(2) exhibited an adequate antitumor effect and was confirmed to be manageable and tolerable in Japanese patients with advanced or recurrent colorectal cancer, who had discontinued oxaliplatin-based regimen.

Trial registration: UMIN000001817 .

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meier curves according to first-line treatment (oxaliplatin-based regimen) with/without bevacizumab. (A) Progresion-free survival (PFS), (B) Overall survival (OS).
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Fig2: Kaplan-Meier curves according to first-line treatment (oxaliplatin-based regimen) with/without bevacizumab. (A) Progresion-free survival (PFS), (B) Overall survival (OS).

Mentions: The response rate, PFS, and OS in patients previously treated with a regimen with bevacizumab were 7.2% (95% CI: 2.4-16.1%), 4.5 months (95% CI: 3.0-5.6 months), and 12.3 months (95% CI: 8.9-14.9 months), respectively, and those in patients previously treated with a regimen without bevacizumab were 20.0% (95% CI: 5.7-43.7%, p = 0.1102), 8.8 months (95% CI: 6.0-13.2 months, HR 2.100, p = 0.0062) and 25.9 months (95% CI: 17.7-NA months, HR 3.650, p < 0.0001) (Figure 2). Additional multivariate analysis including sex, age, ECOG PS, primary tumor site, and pre-treatment with bevacizumab as covariates resulted in HR for OS of 3.773 (p < 0.001) and for PFS of 2.237 (p = 0.008).Figure 2


Multicenter phase II study of FOLFIRI plus bevacizumab after discontinuation of oxaliplatin-based regimen for advanced or recurrent colorectal cancer (CR0802).

Suenaga M, Nishina T, Mizunuma N, Yasui H, Ura T, Denda T, Ikeda J, Esaki T, Nishisaki H, Takano Y, Sugiyama Y, Muro K - BMC Cancer (2015)

Kaplan-Meier curves according to first-line treatment (oxaliplatin-based regimen) with/without bevacizumab. (A) Progresion-free survival (PFS), (B) Overall survival (OS).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4376520&req=5

Fig2: Kaplan-Meier curves according to first-line treatment (oxaliplatin-based regimen) with/without bevacizumab. (A) Progresion-free survival (PFS), (B) Overall survival (OS).
Mentions: The response rate, PFS, and OS in patients previously treated with a regimen with bevacizumab were 7.2% (95% CI: 2.4-16.1%), 4.5 months (95% CI: 3.0-5.6 months), and 12.3 months (95% CI: 8.9-14.9 months), respectively, and those in patients previously treated with a regimen without bevacizumab were 20.0% (95% CI: 5.7-43.7%, p = 0.1102), 8.8 months (95% CI: 6.0-13.2 months, HR 2.100, p = 0.0062) and 25.9 months (95% CI: 17.7-NA months, HR 3.650, p < 0.0001) (Figure 2). Additional multivariate analysis including sex, age, ECOG PS, primary tumor site, and pre-treatment with bevacizumab as covariates resulted in HR for OS of 3.773 (p < 0.001) and for PFS of 2.237 (p = 0.008).Figure 2

Bottom Line: The incidence of grade 3 or higher adverse events was 60.2% for neutropenia, 23.7% for leukopenia, 9.7% for diarrhea, 6.5% for anorexia, and 5.4% for fatigue.All these adverse events and other adverse events were controllable.UMIN000001817 .

View Article: PubMed Central - PubMed

Affiliation: Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan. m.suenaga@jfcr.or.jp.

ABSTRACT

Background: To investigate the efficacy and safety of FOLFIRI plus bevacizumab regimen with irinotecan (180 mg/m(2)) in patients with advanced or recurrent colorectal cancer who were of the wild-type or heterozygous group for UGT1A1*28 and *6 polymorphisms and discontinued to oxaliplatin-based regimen, prospectively.

Methods: The study population consisted of patients who had discontinued oxaliplatin-based regimen for any reason. The primary endpoint was the response rate. FOLFIRI and bevacizumab regimen [irinotecan: 180 mg/m(2), 5-fluorouracil infusion: 2400 mg/m(2), 5-fluorouracil bolus: 400 mg/m(2), levofolinate calcium: 200 mg/m(2), bevacizumab: 5 mg/kg] was repeated every 2 weeks for up to 24 cycles.

Results: Ninety-four patients were enrolled; 93 patients were evaluated on safety, 94 patients on efficacy. The response rate was 10.1% (95% confidence interval (CI): 4.7-18.3%). The median time to treatment failure, progression-free survival, and overall survival were 4.1 months (95% CI: 2.8-4.8 months), 5.4 months (95% CI: 4.1-6.2 months), and 14.5 months (95% CI: 11.8-17.0 months), respectively. The treatment-related death was 1.1%, and the early death ≤30 days after the last study treatment was 1.1%. The incidence of grade 3 or higher adverse events was 60.2% for neutropenia, 23.7% for leukopenia, 9.7% for diarrhea, 6.5% for anorexia, and 5.4% for fatigue. All these adverse events and other adverse events were controllable.

Conclusions: FOLFIRI plus bevacizumab regimen with an initial irinotecan dose of 180 mg/m(2) exhibited an adequate antitumor effect and was confirmed to be manageable and tolerable in Japanese patients with advanced or recurrent colorectal cancer, who had discontinued oxaliplatin-based regimen.

Trial registration: UMIN000001817 .

No MeSH data available.


Related in: MedlinePlus