1. Multicenter phase-II trial of irinotecan plus oxaliplatin [IROX regimen] in patients with poor-prognosis cancer of unknown primary: A hellenic cooperative oncology group study
- Author
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Briassoulis, E. Ch, Fountzilas, George, Bamias, A. T., Dimopoulos, M. A., Xiros, N., Aravantinos, Gerasimos, Samantas, E., Kalofonos, H. P., Makatsoris, T., Mylonakis, N., Papakostas, P., Skarlos, Dimosthenis V., Varthalitis, I., Pavlidis, Nicholas, Pavlidis, Nicholas [0000-0002-2195-9961], Aravantinos, Gerasimos [0000-0002-2106-1713], and Kalofonos, H. P. [0000-0002-3286-778X]
- Subjects
Oncology ,Male ,Survival rate ,Neurologic disease ,Organoplatinum Compounds ,medicine.medical_treatment ,Organoplatinum Compounds/administration & dosage/adverse effects/therapeutic use ,Toxicology ,Treatment response ,Trial ,Cancer growth ,Multiple cycle treatment ,derivatives/therapeutic use ,Drug activity ,Antineoplastic Combined Chemotherapy Protocols ,Pharmacology (medical) ,Disease course ,Liver metastasis ,Depression ,Unknown primary ,Tumor localization ,Prognosis ,Multicenter study ,Clinical trial ,Oxaliplatin ,Cancer of unknown primary ,Adenocarcinoma/drug therapy/mortality/secondary ,Granulocyte colony stimulating factor ,Liver disease ,Drug mechanism ,Human ,Diarrhea ,medicine.medical_specialty ,Clinical article ,Febrile neutropenia ,Weight reduction ,Side effect ,Adenocarcinoma ,Irinotecan ,Disease-Free Survival ,Drug Administration Schedule ,Article ,Combination chemotherapy ,Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse ,Humans ,Aged ,Pharmacology ,Cancer of unknown primary site ,Bone metastasis ,Leukopenia ,medicine.disease ,digestive system diseases ,Regimen ,Atropine ,Cancer Research ,Peripheral neuropathy ,Medical decision making ,Neoplasms ,Nausea and vomiting ,Middle aged ,Organoplatinum compounds ,Visceral metastasis ,Fatigue ,Priority journal ,Drug tolerability ,Drug withdrawal ,Anemia ,Middle Aged ,Anorexia ,Female ,effects/*therapeutic use ,Camptothecin/administration & dosage/adverse effects/analogs & ,medicine.drug ,Adult ,Abdominal pain ,Neutropenia ,Cholinergic syndrome ,Fever ,Disease-free survival ,Neoplasms, Unknown Primary/*drug therapy/mortality ,Loperamide ,Internal medicine ,Antineoplastic combined chemotherapy protocols ,Carcinoma ,medicine ,Chemotherapy ,Phase 2 clinical trial ,Disease severity ,Antineoplastic activity ,Blood cell count ,business.industry ,Drug administration schedule ,Cancer ,Thrombocytopenia ,Cancer survival ,Clinical feature ,Neoplasms, Unknown Primary ,Unknown-primary-carcinoma ,Camptothecin ,Phase-ii ,business ,Antiemetic agent ,Controlled study ,Constipation - Abstract
Background: Cancer of unknown primary (CUP) lacks established therapy although it affects 3% of cancer patients. We evaluated the irinotecan- oxaliplatin combination (IROX regimen) in previously untreated patients with non-favorable subsets of unknown primary carcinomas. Methods: This was a multicenter phase-II trial. Protocol treatment consisted of oxaliplatin 80 mg/m2 followed by irinotecan 160 mg/m2 administered every 3 weeks. The primary end points were response rate and toxicity, and secondary end points were time to progression and survival. Results: Forty-seven patients with liver, bone or multiple visceral metastases entered into the trial and received a median 6 chemotherapy cycles (1-11). The regimen was very well tolerated with one febrile neutropenia case and six cases with diarrhea grade 3 (16%). In intent-to-treat analysis the tumor response rate was 13% (95% CI = 4.8-25.7%) and 12 patients (27%, 95%CI 13.9-40.4%) had at least 4 months' duration of disease stabilization. The median time to progression was 2.7 months and the median survival was 9.5 months, with 40% of patients alive at 1 year. Conclusions: The IROX regimen demonstrated similar efficacy and a favorable toxicity profile compared to other more toxic chemotherapy combinations in patients with poor-prognosis CUP. © 2007 Springer-Verlag. 62 2 277 284
- Published
- 2008