A Phase II Study with 5-Fluorouracil, Folinic Acid and Oxaliplatin (FOLFOX-4 Regimen) in Patients with Metastatic Renal Cell Carcinoma

Bennouna, Jaafar; Delva, R.; Gómez, F.; Lesimple, Thierry; Geoffrois, Lionnel; Linassier, Claude; Chevreau, Christine; Douillard, Jean Yves; Négrier, Sylvie

doi:10.1159/000066518

Cited by 14 publications

(4 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Bennouna et al [30] explored the activity of the FOLFOX-4 regimen, involving twice-weekly administration of 5-FU, folinic acid, and oxaliplatin; their results showed the ineffectiveness of this therapy and discouraged further study of the use of oxaliplatin for RCC. Recently, the activity on mRCC of the most promising doublets with gemcitabine and 5-FU was explored, in particular with the administration of a 5-FU oral precursor, capecitabine.…”

Section: Polychemotherapymentioning

confidence: 99%

Chemotherapy in metastatic renal cell carcinoma today? A systematic review

et al. 2013

View full text Add to dashboard Cite

The prognosis of patients affected by metastatic renal cell carcinoma (mRCC) has improved markedly with targeted therapies. Unfortunately, 20-25% of the patients are refractory to treatment at the first response assessment and most patients will acquire drug resistance during the treatment. Moreover, current data on the clinical activity of targeted agents in poor risk or non-clear-cell mRCC patients are inconclusive because of the absence of prospective trials. Therefore, there are still several patients in need of new therapeutic approaches to improve clinical outcomes. Kidney cancer is historically considered resistant to chemotherapy on the basis that the results of phase II trials have not always been promising. We carried out a systematic review of both monochemotherapy and polychemotherapy alone or combined with immunotherapy or targeted agents in mRCC to define the state of the art and to evaluate further clinical research fields. All retrospectives, phase I/dose finding, phase II and phase III studies on chemotherapy in mRCC, published in the literature from January 2003 to November 2012, with at least 20 patients enrolled, were evaluated. Although the results of clinical trials have often been disappointing, in selected cases of mRCC, chemotherapy may have a promising antitumor activity, particularly when there are sarcomatoid differentiation features, or in highly progressive disease where the combination of doxorubicine plus gemcitabine or capecitabine has yielded interesting results. Chemotherapy may play a role in mRCC, whereas targeted agents and immunotherapy have not yielded durable and satisfactory results; further studies are needed.

show abstract

Section: Polychemotherapymentioning

confidence: 99%

Chemotherapy in metastatic renal cell carcinoma today? A systematic review

et al. 2013

View full text Add to dashboard Cite

show abstract

“…In fact, no objective responses were observed in either a small pilot study of the FOLFOX-4 (5-FU, leucovorin, and L-OHP) regimen 26 or a larger (n ϭ 59) Phase II study of the same regimen. 27 In conclusion, our results suggest a certain level of activity, with an acceptable toxicity profile, for the FIGURE 2. Progression-free survival and overall survival (inset) curves for the entire patient population treated in the current Phase II study.…”

Section: Discussionmentioning

confidence: 49%

Gemcitabine and oxaliplatin in the treatment of patients with immunotherapy‐resistant advanced renal cell carcinoma

Porta

Zimatore

Imarisio

et al. 2004

Cancer

View full text Add to dashboard Cite

BACKGROUNDCurrently, there is no standard treatment for patients with advanced renal cell carcinoma (RCC) who do not experience a response to first‐line immunotherapy. In the current Phase II study, the authors explored the antitumor activity of a combination of gemcitabine and oxaliplatin (L‐OHP) in this setting.METHODSForty‐two patients with RCC who had progressive disease following immunotherapy received gemcitabine (1000 mg/m2 intravenously on Days 1 and 8 every 21 days) and L‐OHP (90 mg/m2 intravenously on Day 1 every 21 days) for a minimum of 2 cycles before responses were evaluated. Responses to treatment and toxicity were recorded according to the Response Evaluation Criteria in Solid Tumors and the National Cancer Institute Common Toxicity Criteria, respectively.RESULTSNo complete responses were recorded; however, 6 patients experienced a partial response (14.28%; 95% confidence interval, 5.43–28.5%), 11 patients (26.19%) had temporary stable disease as a best response, and the remaining 25 patients (59.52%) experienced progression despite receiving treatment. The median time to disease progression was 2.5 months (mean, 3.86 months; range, 1.5–11.0 months), whereas the median overall survival was 9.5 months (mean, 10.46 months; range, 4.0–22.5 months). With regard to toxicity, treatment generally was well tolerated, with only one episode of Grade 4 toxicity and expected episodes of Grade 3 toxicity, including myelosuppression and neuropathy.CONCLUSIONSThe current results suggest that the combination of gemcitabine and L‐OHP possesses a certain level of activity and an acceptable toxicity profile in patients with immunotherapy‐resistant advanced RCC. Cancer 2004. © 2004 American Cancer Society.

show abstract

“…3 The highest response rates were found with vinblastine (optical rejection ratio [ORR], 6.7%), 5-FU (ORR, 6.6%), and floxuridine (ORR, 9.7%). 3,35,36 Combination chemotherapy regimens, including gemcitabine combined with 5-FU or capecitabine, docetaxel combined with capecitabine, or oxiplatin have failed to demonstrate significant improvement in outcomes, [37][38][39] although the combination of gemcitabine and doxorubicin has demonstrated a subset of longterm nonprogressors in patients with previously rapidly progressive or sarcomatoid RCC. 40,41 Chemotherapy is only rarely used today to treat mRCC.…”

Section: Cytotoxic Chemotherapymentioning

confidence: 99%

Immunologics and Chemotherapeutics for Renal Cell Carcinoma

Diamond¹,

Riches

Faltas³

et al. 2014

Semin intervent Radiol

View full text Add to dashboard Cite

Treatment of metastatic renal cell carcinoma remains a challenge for clinicians. Traditional chemotherapy is ineffective and immunotherapy with interleukin-2 is only occasionally beneficial. The development of numerous agents targeting vascular endothelial growth factor and mammalian target of rapamycin signaling pathways that have been studied in phase III trials have resulted in significant improvement in survival for patients with clear cell renal cell carcinoma. Currently available U.S. Food and Drug Administration-approved first line targeted agents include sunitinib, pazopanib, temsirolimus, and bevacizumab (with interferon), while axitinib, everolimus, and sorafenib are most extensively used following progression as second- or third line therapy. Attempts to augment the activity of these agents by combining them together or with chemotherapy or immunotherapy have not yet proven to improve outcomes. As a result, the sequential use of single agents remains the current standard of care.

show abstract

A Phase II Study with 5-Fluorouracil, Folinic Acid and Oxaliplatin (FOLFOX-4 Regimen) in Patients with Metastatic Renal Cell Carcinoma

Cited by 14 publications

References 8 publications

Chemotherapy in metastatic renal cell carcinoma today? A systematic review

Chemotherapy in metastatic renal cell carcinoma today? A systematic review

Gemcitabine and oxaliplatin in the treatment of patients with immunotherapy‐resistant advanced renal cell carcinoma

Immunologics and Chemotherapeutics for Renal Cell Carcinoma

Contact Info

Product

Resources

About