Article

High activity and reduced neurotoxicity of bi-fractionated oxaliplatin plus 5-fluorouracil/leucovorin for elderly patients with advanced colorectal cancer.

S. Croce Hospital, Medical Oncology Unit, Fano.
Annals of Oncology (impact factor: 6.43). 08/2005; 16(7):1147-51. DOI:10.1093/annonc/mdi222 pp.1147-51
Source: PubMed

ABSTRACT The proportion of elderly within the general population is increasing and the incidence of colorectal cancer increases with age. Oxaliplatin and 5-fluorouracil (FU) combination is active in this disease.
This multicenter phase II study was designed to investigate feasibility, efficacy, activity of daily living (ADL) and instrumental activity of daily living (IADL) in elderly patients with metastatic colorectal cancer treated, as first-line chemotherapy, with a bi-fractionated oxaliplatin/5-FU based regimen. Treatment was oxaliplatin 45 mg/m2, leucovorin 200 mg/m2, 5-FU 400 mg/m2 and 22 h continuous infusion of 5-FU 600 mg/m2, all given intravenously on days 1 and 2, every 2 weeks.
Seventy-eight patients were enrolled; median age was 75 years (range 70-85). Among 77 evaluable patients, we observed seven complete responses and 32 partial responses, for an overall response rate of 51% (95% confidence interval 40% to 62%). A stabilization of disease was observed in 25% of patients while 19 patients progressed. Canadian NCI grade 3/4 toxicities were: neutropenia in 32% of patients (febrile in two), diarrhea in 10%, mucositis in 4%, and fatigue in 4%. Sensory neuropathy was mild and occurred as grade 3 in 6% of patients. ADL and IADL scores did not change significantly during treatment.
The bi-fractionated delivery of oxaliplatin plus 5-FU/leucovorin demonstrated high antitumor activity in elderly patients with advanced colorectal cancer. Splitting oxaliplatin administration might reduce incidence of severe neuropathy, although this has to be confirmed by further studies.

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    Article: Capecitabine in combination with oxaliplatin or irinotecan in elderly patients with advanced colorectal cancer: results of a randomized phase II study.
    G Rosati, S Cordio, R Bordonaro, G Caputo, G Novello, G Reggiardo, L Manzione
    [show abstract] [hide abstract]
    ABSTRACT: To determine the efficacy and tolerability of capecitabine combined with oxaliplatin (CAPOX) or irinotecan (CAPIRI) as first-line treatment in patients with advanced/metastatic colorectal cancer aged > or =70 years. Patients aged > or =70 years were randomly assigned to receive CAPOX [oxaliplatin 65 mg/m(2) intravenously (i.v.) days 1 and 8 and capecitabine 1000 mg/m(2) orally b.i.d. days 1-14; q21d] or CAPIRI (irinotecan 80 mg/m(2) i.v. days 1 and 8 and capecitabine 1000 mg/m(2) orally b.i.d. days 1-14; q21d). The primary study end point was overall response rate (ORR). Ninety-four patients were enrolled. In an intent-to-treat analysis, 2 complete responses (CRs) and 16 partial responses (PRs) were reported with CAPOX (ORR 38%), and 2 CRs and 15 PRs with CAPIRI (ORR 36%; P = 0.831). Median time to progression was 8 months for CAPOX and 7 months for CAPIRI (P = 0.195), with median survival times of 19.3 months and 14.0 months (P = 0.165), respectively. Global health status was improved in 45% and in 21% of patients in the CAPOX and CAPIRI arms, respectively. The most common treatment-related grade 3-4 adverse events in CAPIRI versus CAPOX patients were diarrhea (32% versus 15%; P = 0.052) and neutropenia (23% versus 6%; P = 0.021). CAPOX and CAPIRI had similar efficacy in elderly patients, although CAPOX seemed to be better tolerated.
    Annals of Oncology 09/2009; 21(4):781-6. · 6.43 Impact Factor
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    Article: Capecitabine in combination with oxaliplatin oririnotecan in elderly patients with advanced colorectalcancer: results of a randomized phase II study
    G Rosati, S Cordio, R Bordonaro, G Caputo, G Novello, G Reggiardo, L Manzione
    [show abstract] [hide abstract]
    ABSTRACT: Background: To determine the efficacy and tolerability of capecitabine combined with oxaliplatin (CAPOX) or irinotecan (CAPIRI) as first-line treatment in patients with advanced/metastatic colorectal cancer aged 70 years. Patients and methods: Patients aged 70 years were randomly assigned to receive CAPOX [oxaliplatin 65 mg/m 2 intravenously (i.v.) days 1 and 8 and capecitabine 1000 mg/m 2 orally b.i.d. days 1–14; q21d] or CAPIRI (irinotecan 80 mg/m 2 i.v. days 1 and 8 and capecitabine 1000 mg/m 2 orally b.i.d. days 1–14; q21d). The primary study end point was overall response rate (ORR). Results: Ninety-four patients were enrolled. In an intent-to-treat analysis, 2 complete responses (CRs) and 16 partial responses (PRs) were reported with CAPOX (ORR 38%), and 2 CRs and 15 PRs with CAPIRI (ORR 36%; P = 0.831). Median time to progression was 8 months for CAPOX and 7 months for CAPIRI (P = 0.195), with median survival times of 19.3 months and 14.0 months (P = 0.165), respectively. Global health status was improved in 45% and in 21% of patients in the CAPOX and CAPIRI arms, respectively. The most common treatment-related grade 3–4 adverse events in CAPIRI versus CAPOX patients were diarrhea (32% versus 15%; P = 0.052) and neutropenia (23% versus 6%; P = 0.021). Conclusion: CAPOX and CAPIRI had similar efficacy in elderly patients, although CAPOX seemed to be better tolerated.
    Annals of Oncology 01/2010; 21(21):781-786. · 6.43 Impact Factor
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    Article: Reduced dose intensity FOLFOX-4 as first line palliative chemotherapy in elderly patients with advanced colorectal cancer.
    Jee Hyun Kim, Do-Youn Oh, Yu Jung Kim, Sae Won Han, In-Sil Choi, Dong-Wan Kim, Seock-Ah Im, Tae-You Kim, Jong-Seok Lee, Dae-Seog Heo, Yung-Jue Bang, Noe Kyeong Kim
    [show abstract] [hide abstract]
    ABSTRACT: To evaluate the toxicity and efficacy of a reduced dose intensity (mini-) FOLFOX-4 regimen as a first-line palliative chemotherapy in elderly patients (> or =70 yr of age) with advanced colorectal cancer, data from prospective databases at Seoul National University Bundang Hospital and Seoul Municipal Boramae Hospital were analyzed. A total of 20 patients were enrolled between January 2001 and August 2004, and were treated with oxaliplatin 65 mg/m2 on day 1, and with 2-hr infusions of leucovorin 150 mg/m2 followed by a 5-FU bolus (300 mg/m2) and 22-hr continuous infusions (450 mg/m2) for 2 consecutive days every 2 weeks until progression, unacceptable toxicity or patient refusal. Sixteen patients were evaluable for response with an overall response rate of 43.8%. Median progression-free survival was 4.8 months (95% CI: 3.0-6.7) and overall survival was 13.5 months (95% CI: 11.1-16.0). The main side effects were anemia and neutropenia, which were observed in 20.8% and 17.7%, respectively, of the total cycles administered. There were no grade 4 toxicities and only one patient suffered from febrile neutropenia. No grade 3 toxicities occurred except for anemia (5.2%) and vomiting (1.0%). In conclusion, the mini-FOLFOX-4 regimen was found to be well tolerated with acceptable toxicity, and to provide a benefit for elderly patients with colorectal cancer.
    Journal of Korean Medical Science 11/2005; 20(5):806-10. · 0.99 Impact Factor
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Keywords

19 patients progressed
 
22 h continuous infusion
 
32 partial responses
 
77 evaluable patients
 
95% confidence interval 40%
 
bi-fractionated delivery
 
bi-fractionated oxaliplatin/5-FU
 
Canadian NCI grade 3/4 toxicities
 
colorectal cancer
 
colorectal cancer increases
 
complete responses
 
days 1
 
elderly patients
 
general population
 
grade 3
 
metastatic colorectal cancer
 
multicenter phase II study
 
response rate
 
Sensory neuropathy
 
Splitting oxaliplatin administration