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Journal ArticleDOI

FOLFOX-4 Regimen as a First-line Therapy for Cuban Patients with Metastatic Colorectal Cancer

01 Jul 2009-MEDICC Review (MEDICC Rev)-Vol. 11, Iss: 3, pp 34-38
TL;DR: In patients studied, the FOLFOX-4 combination was shown to be an effective and well-tolerated therapeutic option for treating inoperable metastatic colorectal cancer.
Abstract: In Cuba, colorectal cancer (CRC) is the malignant neoplasm with the fourth-highest incidence and third-highest mortality. Over one-third of CRC patients exhibit metastatic disease at the time of diagnosis. Standard treatment for metastatic CRC is a 5-fluorouracil (5-FU) + Folinic Acid (FA) continuous infusion regimen. International studies have shown, however, that systemic therapy using oxaliplatin combined with 5-FU and FA (FOLFOX-4) improves results in terms of both tumor response and survival in patients with inoperable metastatic CRC. Objective Evaluate the FOLFOX-4 regimen as a first-line therapy for patients with inoperable metastatic CRC in Cuba. Methods FOLFOX-4 therapy was administered to 56 patients with metastatic CRC, in a treatment cycle repeated every 2 weeks for 6-8 cycles. Patients were followed up for a period of 2 years. Results Objective response was attained in 44.6% of patients, and complete response in 12.5%. Median duration of response and of progression-free survival was 9.6 and 8.9 months, respec- tively. Estimated survival at 2 years was 17% (95% CI: 6.89- 26.8). The most frequent adverse events were nausea, vomit- ing, diarrhea and neutropenia, the majority grade 1-2, according to Common Terminology Criteria for Adverse Events (CTCAE) classification. Conclusions In patients studied, the FOLFOX-4 combination was shown to be an effective and well-tolerated therapeutic option for treating inoperable metastatic colorectal cancer.

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Journal ArticleDOI
TL;DR: Metformin may be a promising drug in protecting colorectal cancer patients against oxaliplatin-induced chronic peripheral sensory neuropathy and mean serum levels of malondialdehyde and neurotensin were significantly lower after the 6th and the 12th cycles.
Abstract: Peripheral sensory neuropathy is the most prominently reported adverse effect of oxaliplatin. The purpose of this study was to evaluate metformin role in oxaliplatin-induced neuropathy. From November 2014 to May 2016, 40 patients with stage III colorectal cancer completed 12 cycles of FOLFOX-4 regimen. Twenty patients in the control arm received FOLFOX-4 regimen only, and 20 patients in the metformin arm, received the same regimen along with metformin 500 mg three times daily. The metformin efficacy was evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0), a12-item neurotoxicity questionnaire (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group and, the brief pain inventory short form “worst pain” item. In addition to neurotensin, malondialdehyde and interleukin-6 serum levels assessment. At the end of the 12th cycle, there were less patients with grade 2 and 3 neuropathy in metformin arm as compared to control arm. (60 versus 95%, P = 0.009) In addition, metformin arm showed significantly higher total scores of Ntx-12 questionnaire than control arm (24.0 versus 19.2, P < 0.001). Furthermore, the mean pain score in metformin arm was significantly lower than those of control arm, (6.7 versus 7.3, P = 0.005). Mean serum levels of malondialdehyde and neurotensin were significantly lower in metformin arm after the 6th and the 12th cycles. Metformin may be a promising drug in protecting colorectal cancer patients against oxaliplatin-induced chronic peripheral sensory neuropathy.

31 citations

Journal ArticleDOI
TL;DR: Although infrequent, pulmonary toxicity can occur in association with FOLFOX therapy and Cessation of therapy and prompt initiation of corticosteroids may improve outcomes.
Abstract: Background. Oxaliplatin in combination with 5-fluorouracil (5-FU) and leucovorin (FOLFOX) is a common chemotherapeutic regimen for advanced colorectal cancer. Here, we present a case of interstitial lung disease associated with FOLFOX therapy. Case report. A 74-year-old man with a history of metastatic colorectal cancer was admitted with a four week history of progressive dyspnoea and evidence of severe respiratory failure. He had recently completed six cycles of FOLFOX chemotherapy in the months prior to presentation. Investigations did not reveal convincing evidence of infection or pulmonary embolism. CT chest demonstrated widespread pulmonary infiltrates and interlobular septal thickening. The patient was commenced on both broad spectrum antibiotic therapy and high dose corticosteroid treatment however his respiratory failure continued to progress. The patient died four days after admission due to progressive respiratory failure. Subsequent post-mortem examination demonstrated evidence of diffuse alveolar damage without evidence of tumour infiltration, infection or pulmonary embolism. Conclusions. Although infrequent, pulmonary toxicity can occur in association with FOLFOX therapy. Cessation of therapy and prompt initiation of corticosteroids may improve outcomes.

2 citations

References
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Journal ArticleDOI
Kenji Omura1
TL;DR: A meta-analysis which analyzed 21 randomized controlled trials revealed that a combination of 5-FU and LV doubled the response rate compared with5-FU alone and prolonged the median survival time by about 1 month, which should prolong the survival of advanced or metastatic colorectal cancer by 2–3 months in combination with FOLFIRI or FOLFOX.
Abstract: In the early 1990s, some prospective controlled trials revealed the superiority of chemotherapy for survival compared with best supportive care for advanced or metastatic colorectal carcinoma. Until r

38 citations

Journal ArticleDOI
TL;DR: Responses observed with oxaliplatin and 5-fluorouracil indicate synergy between the two agents and the combination of capecitabine plus oxali Platin or irinotecan has shown high activity both in chemotherapy-naive and in pretreated patients with advanced colorectal cancer.

28 citations

Journal ArticleDOI
TL;DR: Recent data on oxaliplatin, cetuximab and the combination of both for mCRC as well as possible future indications in the palliative, adjuvant and neoadjuvant setting of modern CRC treatment are presented.
Abstract: Modern chemotherapy combinations for metastatic colorectal cancer (mCRC) comprise 5-fluorouracil (5-FU), folinic acid and irinotecan or oxaliplatin. Infusional 5-FU, folinic acid plus oxaliplatin (FOLFOX) is a standard of care not only for patients with stage IV disease, but also in the adjuvant setting of stage III colon cancer patients. The EGF receptor antibody, cetuximab, induces synergistic antitumor activity when combined with chemotherapy. In pretreated patients, cetuximab may restore the sensitivity to irinotecan and, therefore, has been registered in this setting. A number of Phase I and II trials investigated the combination of cetuximab plus oxaliplatin-based chemotherapy for the first-line treatment of mCRC. This combined cytotoxic and targeted treatment approach prooved to be safe and provided encouraging efficacy data, which are among the highest so far observed in the systemic treatment of mCRC. This review presents recent data on oxaliplatin, cetuximab and the combination of both for mCRC as well as possible future indications in the palliative, adjuvant and neoadjuvant setting of modern CRC treatment.

14 citations

01 Jan 2008
TL;DR: Recent data on oxaliplatin, cetuximab and the combination of both for mCRC as well as possible future indications in the palliative, adjuvant and neoadjuvant setting of modern CRC treatment are presented.
Abstract: Modern chemotherapy combinations for metastatic colorectal cancer (mCRC) comprise 5-fluorouracil (5-FU), folinic acid and irinotecan or oxaliplatin. Infusional 5-FU, folinic acid plus oxaliplatin (FOLFOX) is a standard of care not only for patients with stage IV disease, but also in the adjuvant setting of stage III colon cancer patients. The EGF receptor antibody, cetuximab, induces synergistic antitumor activity when combined with chemotherapy. In pretreated patients, cetuximab may restore the sensitivity to irinotecan and, therefore, has been registered in this setting. A number of Phase I and II trials investigated the combination of cetuximab plus oxaliplatin-based chemotherapy for the first-line treatment of mCRC. This combined cytotoxic and targeted treatment approach prooved to be safe and provided encouraging efficacy data, which are among the highest so far observed in the systemic treatment of mCRC. This review presents recent data on oxaliplatin, cetuximab and the combination of both for mCRC as well as possible future indications in the palliative, adjuvant and neoadjuvant setting of modern CRC treatment.

6 citations

Journal ArticleDOI
TL;DR: FOLFOX treatment allowed 14 % of unresectable patients to be rescued by surgery, and there was no additional benefit to perform surgery after 6 months of therapy compared to early surgery.
Abstract: 3522 Background: Surgery of metastasis can cure arround 20% of metastatic colorectal cancer (MCRC) patients. The Optimox 1 study achieved a response rate over 50% with FOLFOX therapy in patients (pts) with initially unresectable metastasis which allowed to perform surgery in a significant number of pts (JCO 2006). We report here the results in pts who underwent surgery of metastasis (met). Methods: From jan 2000 to june 2002, 620 previously untreated patients with unresectable metastasis were randomized between FOLFOX4 every two weeks until progression (arm A), or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles and reintroduction of FOLFOX7 (arm B). 101 pts were resected with a curative intent, 57 in arm A and 45 in arm B. Results: Patients characteristics were (arm A/B %): metachronous metastasis 77/51, liver met 82/91, lung met 16/11, other met 7/4, PAL < 3 ULN: 98/97, normal LDH: 52/51. 8% of pts achieved a complete response, 72% a partial response, 16% a stable disease. 89 pts had ...

5 citations