| Name |
Creator |
1 Oxaliplatin "Package Insert"
from 8/9/02. "The approval of ELOXATIN is based on response rate and an interim analysis showing improved time to radiographic progression. No results are available at this time that demonstrate a clinical benefit, such as improvement of disease-related symptoms or increased survival"
http://www.fda.gov/cder/foi/label/2002/21492lbl.pdf |
altman23
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2 Eloxitan (Oxaliplatin) Product Information
Summary from Sanofi (manufacturer) as of April 2002. Gives details of clinical trial results, efficacy and safety. Some of these trials were part of the original FDA submission in 2000 which was rejected due to lack of efficacy. While Oxaliplatin was shown to have tumor response, it did not increase survival time in these trials.
http://www.sanofi-synthelabo.com.au/pdf/eloxatin-pi.pdf |
altman23
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3 Basis of the FDA Oxaliplatin approval
is as a second line therapy following 5-FU/LV/Camptosar failure. The tumor response rate (definition: 30% or greater reduction in overall tumor size, maintained for 4 weeks or more) in this patient population was 9%
http://www.sanofi-synthelabous.com/news/2002/20020812.html |
altman23
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4 For Officials at the FDA, Drug Tests Can Be a Trial
Discussion of Oxaliplatin approval by the FDA
http://groups.yahoo.com/group/experimentalandunconventional/message/836 |
altman23
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A Randomized Controlled Trial of Fluorouracil Plus Leucovorin, Irinotecan, and Oxaliplatin Combinations in Patients With Previously Untreated Metastatic Colorectal Cancer
J Clin Oncol. 2004 Jan 1;22(1):23-30. Epub 2003 Dec 09 A total of 795 patients were randomly assigned between May 1999 and April 2001. A median time to progression of 8.7 months, response rate of 45%, and median survival time of 19.5 months were observed for FOLFOX. These results were significantly superior to those observed for IFL for all end points (6.9 months, 31%, and 15.0 months, respectively) or for IROX (6.5 months, 35%, and 17.4 months, respectively) for time to progression and response. The FOLFOX regimen had significantly lower rates of severe nausea, vomiting, diarrhea, febrile neutropenia, and dehydration. Sensory neuropathy and neutropenia were more common with the regimens containing oxaliplatin. CONCLUSION The FOLFOX regimen of oxaliplatin and infused fluorouracil plus leucovorin was active and comparatively safe. It should be considered as a standard therapy for patients with advanced colorectal cancer.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14665611&dopt=Abstract |
altman23
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Eloxatin (Oxaliplatin for Injection) Patient Information
This site contains information on Eloxatin(Oxaliplatin for a patient. Introduces new patient to information on this chemo drug.
http://www.eloxatin.com/patient/index.asp |
becbeach
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Emerging Options in Chemotherapy (Fall 2000 Newsletter)
In April 2000, the FDA denied approval of oxaliplatin in combination with 5-FU and leucovorin as a first-line treatment regimen for metastatic or recurrent CRC. While the FDA Oncologic Drug Advisory Committee (ODAC) acknowledged that oxaliplatin is effective against colorectal cancer, the application was denied because the data did not clearly show a survival benefit when compared to the thenstandard 5-FU/leucovorin combination. The ODAC committee members suggested that additional data showing a clear survival benefit for either first- line or second-line treatment is needed before FDA approval would be granted in either case. The manufacturer is currently working with the FDA to develop the appropriate data.
http://www.ccalliance.org/connect/newsletter/fall00/emerging.html |
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FOLFIRI Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: A Randomized GERCOR Study
J Clin Oncol. 2003 Dec 2 RESULTS: Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI (P =.99). Median second progression-free survival (PFS) was 14.2 months in arm A versus 10.9 in arm B (P =.64). In first-line therapy, FOLFIRI achieved 56% response rate (RR) and 8.5 months median PFS, versus FOLFOX6 which achieved 54% RR and 8.0 months median PFS (P =.26). Second-line FOLFIRI achieved 4% RR and 2.5 months median PFS, versus FOLFOX6 which achieved 15% RR and 4.2 months PFS. In first-line therapy, National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis, nausea/vomiting, and grade 2 alopecia were more frequent with FOLFIRI, and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6. CONCLUSION: Both sequences achieved a prolonged survival and similar efficacy. The toxicity profiles were different
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14657227&dopt=Abstract |
altman23
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Long-term survival of patients with unresectable CC liver metastases following infusional chemo with 5-FU/LV Oxal and Surgery
Ann Oncol 1999 Jun;10 PMID: 10442188 From March 1988 to June 1994, 151 patients with colorectal liver metastases were considered initially unresectable...The size of liver metastases decreased by > 50% in 89 patients (59%) and median overall survival was 24 months , with 28% surviving at five years. Surgery with curative intent was attempted in 77 patients (51%), complete resection of liver metastases was achieved in 58 patients (38%). The median survival of the 77 operated patients was 48 months (25-71), with a five-year survival rate of 50% (38-61). CONCLUSION: This new strategy of combining effective chemotherapy with surgery apparently altered the natural history of unresectable colorectal cancer metastases.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10442188&dopt=Abstract |
altman23
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Metastatic Colorectal Cancer
May/June 2003 Moffit Cancer Control Journal Article - full text
http://www.moffitt.usf.edu/pubs/ccj/v10n3/pdf/224.pdf |
altman23
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Multicenter Phase II Study of Nordic Fluorouracil and Folinic Acid Bolus Schedule Combined With Oxaliplatin As First-Line Treatm
J Clin Oncol. 2004 Jan 1;22(1):31-38 Results Fifty-one of 82 assessable patients achieved a complete (n = 4) or partial (n = 47) response, leading to a response rate of 62% (95% CI, 52% to 72%). Nineteen patients showed stable disease, and 12 patients had progressive disease. Thirty-eight of the 51 responses were radiologically confirmed 8 weeks later (confirmed response rate, 46%; 95% CI, 36% to 58%). The estimated median time to progression was 7.0 months (95% CI, 6.3 to 7.7 months), and the median overall survival was 16.1 months (95% CI, 12.7 to 19.6 months) in the intent-to-treat population. Neutropenia was the main adverse event, with grade 3 to 4 toxicity in 58% of patients.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14701765&dopt=Abstract |
altman23
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New Therapeutic Options in Colon Cancer - Focus on Oxalipaltin
Article from the Clinical Journal of Oncology Nursing. Discussion of toxicity and its management, nursing plan, etc.
http://www.ons.org/images/Library/ons_publications/cjon/2002/May_June_2002/131-137.pdf |
altman23
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Oncosurgery: a new reality in metastatic colorectal carcinoma.
Semin Oncol 2002 Oct;29 PMID: 12422303 In a recent study in 389 such patients, 151 of which had liver-only metastases, 51% treated with oxaliplatin became resectable with some patients achieving a complete histologic response. In another series of 95 initially unresectable patients who became resectable after treatment with oxaliplatin-based therapy, 41% were still alive after 4.2 years, with 64% of these being recurrence-free
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12422303&dopt=Abstract |
altman23
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Oxaliplatin Plus 5-Fluorouracil/Leucovorin May Be More Effective than 5-Fluorouracil/Leucovorin Alone (2000)
In Switzerland, 200 patients with metastatic cancer of the colon or rectum received 1 of 2 therapies: either 5-fluorouracil/leucovorin or 5-fluorouracil/leucovorin plus oxaliplatin. The group receiving the oxaliplatin combination had a 53% response rate, compared with only 16% in the those who did not receive oxaliplatin
http://www.ccalliance.org/news/treatment/ctcnews/oxaliplatin.html |
altman23
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Oxaliplatin With High-Dose Leucovorin and Infusional 5-Fluorouracil in Irinotecan-Pretreated Patients With Advanced Colon Cancer
complete response was achieved in one (2.4%) and partial response in six (14.6%) patients (overall response rate: 17%; 95% CI: 5.56-28.59%); stable disease and progressive disease were observed in 15 (36.6%) and in 19 (46.31%) patients, respectively. The median duration of response and the median time to tumor progression were 6 and 8.5 months, respectively. The median overall survival was 12 months and the probability for 1-year survival was 42.9%.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12478014&dopt=Abstract |
altman23
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Oxaliplatin as First Line Therapy
The mature data that we are reporting today substantiates the early data presented last year that patients with advanced colorectal cancer definitely live longer with the FOLFOX regimen,” says Dr. Goldberg. “We found that patients with advanced colorectal cancer lived an average of 19.5 months on the FOLFOX regimen, compared with 14.8 months for patients receiving the standard IFL treatment. The one-year average survival was 72 percent for patients receiving the FOLFOX regimen versus 59 percent for patients on the IFL treatment.
http://www.mayoclinic.org/news2003-rst/1828.html |
altman23
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Platinum-Based Chemotherapy Carries Increased Risk of Leukemia
Based on these observations and the drug regimens used in their study, the authors estimated that out of 10,000 ovarian cancer patients treated for six months with 500 mg to 1,000 mg of cisplatin, an excess of 21 leukemias might be expected to occur in the following decade; at doses of 1,000 mg and greater, an excess of 71 leukemias might be expected.
http://www.nih.gov/news/pr/feb99/nci-03.htm |
altman23
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The FDA Redefines "Fast"
The Wall Street Journal was not impressed with the FDA's "record time" approval of Oxaliplatin
http://groups.yahoo.com/group/experimentalandunconventional/message/573 |
altman23
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Treatment of Colorectal Cancer: An Overview of the Latest Data
Colorectal cancer has been notoriously difficult to treat successfully. Despite numerous attempts at modifying existing therapeutic regimens or designing new ones, survival rates for nonresectable tumors remain low. Nevertheless, studies presented at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO) demonstrate the continued progress that researchers are making in this arena and highlight the incremental advances in treatment.
http://www.medscape.com/viewarticle/436140 |
altman23
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Use of oxaliplatin-containing regimens as first-line treatment of metastatic disease
The data suggest you can administer either irinotecan or oxaliplatin as first-line therapy, but there’s been a paradigm shift. Intergroup N9741 demonstrated clear superiority of FOLFOX 4 with oxaliplatin and infusonal 5-FU over a bolus IFL regimen, and I’m not sure that the results would have been different if infusional 5-FU had been used with irinotecan. Patients tolerate oxaliplatin better, and the responses are more impressive. Off study, I’m using a modified FOLFOX regimen, with leucovorin on day one followed by a 46-hour 5-FU infusion after a bolus.
http://www.colorectalcancerupdate.com/edition/2003/2/hochster.htm |
altman23
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