In clinical studies Oxaliplatin by itself has modest activity against advanced colorectal cancer.5 It has been extensively studied in combination with Fluorouracil and Folinic Acid (a combination known as FOLFOX). When compared with Fluorouracil and Folinic Acid administered according to the "De Gramont regimen" there was no significant increase in overall survival with the FOLFOX regimen (specifically FOLFOX4) but progression-free survival the primary end-point of the phase III randomized trial was improved with FOLFOX.6 Adjuvant treatment of colorectal cancer

After the curative resection of colorectal cancer chemotherapy based on Fluorouracil and folinic acid reduces the risk of relapse. The benefit is clinically relevant when cancer has spread to locoregional lymph nodes (stage III Dukes C). The addition of Oxaliplatin improves relapse-free survival but data on overall survival have not yet been published in extenso. When cancer has not spread to the locoregional lymph nodes (stage II Dukes B) the benefit of chemotherapy is marginal and the decision on whether to give adjuvant chemotherapy should be carefully evaluated by discussing with the patient the realistic benefits and the possible toxic side effects of treatment. This is even more relevant when the oncologist proposes treatment with Oxaliplatin. Adverse effects

Side-effects of oxaliplatin treatment can potentially include: Neuropathy (both an acute reversible sensitivity to cold and numbness in the hands and feet and a chronic possibly irreversible foot/leg hand/arm numbness often with deficits in proprioception)7 Fatigue Nausea vomiting and/or diarrhea Neutropenia Ototoxicity (hearing loss) Extravasation if Oxaliplatin leaks from the infusion vein it may cause severe damage to the connective tissues. Hypokalemia which is more common in women than men8

In addition some patients may experience an allergic reaction to platinum-containing drugs. This is more common in women.8 Oxaliplatin has less ototoxicity and nephrotoxicity than cisplatin and carboplatin.7 Patent information Eloxatin is covered by patent numbers 5338874 (Expiry Apr 072013) 5420319 (Expiry Aug 082016) 5716988 (Expiry Aug 072015) and 5290961 (Expiry Jan 12 2013) (see Electronic Orange Book patent info for Eloxatin).9 Exclusivity code I-441 which expired on Nov 04 2007 is for use combination with infusional 5-FU/LV for adjuvant treatment stage III colon cancer patients who have undergone complete resection primary tumor-based on improvement in disease free survival with no demonstrated benefit overall survival after 4 years. Exclusivity code NCE New Chemical Entity expired on Aug 09 2007.9 References Ehrsson H Wallin I Yachnin J. Medical Oncology. 2002; 19:251-265. The status of platinum anticancer drugs in the clinic and in clinical trials Dalton Transactions 2010 39 8113-8127 Direct Cellular Responses to Platinum-Induced DNA Damage. Yongwon Jung and Stephen J. Lippard Chem. Rev. 107 1387-1407 (2007).doi:10.1021/cr068207j Generic Oxaliplatin Approved Becouarn Y Ychou M Ducreux M et al. Phase II trial of oxaliplatin as first-line chemotherapy in metastatic colorectal cancer patients. Digestive Group of French Federation of Cancer Centers. J Clin Oncol 1998; 16(8):2739-44. PMID 9704726. de Gramont A Figer A Seymour M et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000; 18(16):2938-47. PMID 10944126 a b Pasetto LM D'Andrea MR Rossi E Monfardini S. Oxaliplatin-related neurotoxicity: how and why Crit Rev Oncol Hematol. 2006 Aug;59(2):159-68. Pub. June 27 2006. PMID 16806962. a b Chay WY Chew L Yeoh TT Tan MH. An association between transient hypokalemia and severe acute oxaliplatin-related toxicity predominantly in women. Acta Oncologica. May 2010 Vol. 49 No. 4 Pages 515-517. PMID: 20092386. a b Orange Book. accessdata.fda.gov. URL: http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfmApplNo021759&ProductNo001&table1OBRx. Accessed on: July 22 2007. External links Oxaliplatin - Official web site of manufacturer. Oxaliplatin Prescribing Information - Official prescribing information. Virtual Cancer Centre: Oxaliplatin/Eloxatin NCI Drug Information Summary on Oxaliplatin Additional sources "Oxaliplatin." (PDF). Nat Rev Drug Discov 3 (1): 112. 2004. PMID 14756144. http://www.dresources.com/nature/ntr0104.pdf.  v d eIntracellular chemotherapeutic agents/antineoplastic agents (L01) SPs/MIs (M phase) Block microtubule assembly Vinca alkaloids (Vinblastine Vincristine Vinflunine Vindesine Vinorelbine) Block microtubule disassembly Taxanes (Cabazitaxel Docetaxel Larotaxel Ortataxel Paclitaxel Tesetaxel)  Epothilones (Ixabepilone) DNA replication inhibitor DNA precursors/ antimetabolites (S phase) Folic acid dihydrofolate reductase inhibitor (Aminopterin Methotrexate Pemetrexed Pralatrexate)  thymidylate synthase inhibitor (Raltitrexed Pemetrexed) Purine adenosine deaminase inhibitor (Pentostatin) halogenated/ribonucleotide reductase inhibitors (Cladribine Clofarabine Fludarabine) thiopurine (Thioguanine Mercaptopurine) Pyrimidine thymidylate synthase inhibitor (Fluorouracil Capecitabine Tegafur Carmofur Floxuridine) DNA polymerase inhibitor (Cytarabine) ribonucleotide reductase inhibitor (Gemcitabine) hypomethylating agent (Azacitidine Decitabine) Deoxyribonucleotide ribonucleotide reductase inhibitor (Hydroxycarbamide) Topoisomerase inhibitors (S phase) I Camptotheca (Camptothecin Topotecan Irinotecan Rubitecan Belotecan) II Podophyllum (Etoposide Teniposide) II+Intercalation Anthracyclines (Aclarubicin Daunorubicin Doxorubicin Epirubicin Idarubicin Amrubicin Pirarubicin Valrubicin Zorubicin)  Anthracenediones (Mitoxantrone Pixantrone) Crosslinking of DNA (CCNS) Alkylating Nitrogen mustards: Mechlorethamine  Cyclophosphamide (Ifosfamide Trofosfamide)  Chlorambucil (Melphalan Prednimustine)  Bendamustine  Uramustine  Estramustine Nitrosoureas: Carmustine  Lomustine (Semustine)  Fotemustine  Nimustine  Ranimustine  Streptozocin Alkyl sulfonates: Busulfan (Mannosulfan Treosulfan) Aziridines: Carboquone  ThioTEPA  Triaziquone  Triethylenemelamine Alkylating-like Platinum (Carboplatin Cisplatin Nedaplatin Oxaliplatin Triplatin tetranitrate Satraplatin) Nonclassical Hydrazines (Procarbazine)  Triazenes (Dacarbazine Temozolomide)  Altretamine  Mitobronitol Intercalation Streptomyces (Actinomycin Bleomycin Mitomycin Plicamycin) Photosensitizers/PDT Aminolevulinic acid/Methyl aminolevulinate  Efaproxiral  Porphyrin derivatives (Porfimer sodium Talaporfin Temoporfin Verteporfin) Other Enzyme inhibitors FI (Tipifarnib)   CDK inhibitors (Alvocidib Seliciclib)  PrI (Bortezomib)  PhI (Anagrelide)  IMPDI (Tiazofurine)  LI (Masoprocol)  PARP inhibitor (Olaparib)  HDAC (Vorinostat Romidepsin) Receptor antagonists ERA (Atrasentan)  retinoid X receptor (Bexarotene)  sex steroid (Testolactone) Other/ungrouped Amsacrine  Trabectedin  retinoids (Alitretinoin Tretinoin)  Arsenic trioxide  asparagine depleters (Asparaginase/Pegaspargase)  Celecoxib  Demecolcine  Elesclomol  Elsamitrucin  Etoglucid  Lonidamine  HAMLET (human alpha-lactalbumin made lethal to tumor cells)  Lucanthone  Mitoguazone  Mitotane  Oblimersen  Omacetaxine mepesuccinate  mTOR inhibitors (Everolimus Temsirolimus) M: NEO tsoc mrkr tumr epon para drug (L1i/1e/V03)