Jean-Jacques Voigt

Cisplatin in Combination With Either Gemcitabine or Irinotecan in Carcinomas of Unknown Primary Site: Results of a Randomized Phase II Study—Trial for the French Study Group on Carcinomas of Unknown Primary (GEFCAPI 01)

PURPOSE To evaluate the efficacy and toxicity of novel chemotherapy combinations including cisplatin with gemcitabine (GC) or irinotecan (IC) for patients with carcinomas of an unknown primary site. PATIENTS AND METHODS Eighty patients were randomly assigned to receive GC or IC. In the GC arm, chemotherapy consisted of cycles combining gemcitabine 1,250 mg/m2 intravenously (IV) on days 1 and 8, and cisplatin 100 mg/m2 IV on day 1 at 3-week intervals. Patients in the IC arm originally received 3-week cycles of irinotecan 200 mg/m2 IV on day 1 and cisplatin 80 mg/m2 IV on day 1. After the inclusion of 15 patients in that arm, the toxicity profile required the irinotecan doses to be reduced to 150 mg/m2 per cycle. Independent histologic and radiologic reviews were done. RESULTS A total of 78 patients were assessable for efficacy and toxicity. The median number of cycles was four in each arm. Objective responses were observed in 21 patients (55%) in the GC arm (95% CI, 34% to 66%) and in 15 patients (38%) in the IC arm (95% CI, 23% to 54%). Treatment had to be stopped because of toxicity in seven patients in the GC arm and in eight patients in the IC arm. With a median follow-up of 22 months, the median survivals were 8 and 6 months in the GC and IC arms, respectively. CONCLUSION This study demonstrates the activity of both the GC and IC regimens. There was toxicity associated with both regimens. Additional studies of combination chemotherapy regimens are required.

Bulletin de synthèse de veille 2006

RésuméContexteLa validité des recommandations repose sur leur actualisation au même titre que sur la rigueur du développement initial. Dans ce contexte, les Standards, options et recommandations (SOR) de la Fédération nationale des centres de lutte contre le cancer (FNCLCC) ont mis en place un programme de veille dont l’objectif est de surveiller l’appartition de nouvelles données.ObjectifsIdentifier les informations susceptibles de modifier les recommandations du document « SOR pour la prise en charge des patients atteints de carcinome de site primitif inconnu (2002) », analyser leur impact et informer les utilisateurs sur la validité des recommandations au vu des nouvelles données.MéthodesLe processus de veille repose sur trois étapes conduites en collaboration avec des experts: la collecte des données à partir de différentes sources, la sélection et le classement des informations, puis leur traitement.RésultatsÀ l’issue du processus de veille, les recommandations relatives au traitement des métastases cervicales d’un carcinome épidermoïde ont été identifiées comme devant être mises à jour. Toutes les autres recommandations du document initial sont valides (jugement argumenté des experts du groupe de travail).AbstractContextThe validity of clinical practice guidelines is based on their regular update as well as the quality of the initial guideline development process. The Standards, options and recommendations (SOR) of the French National Federation of Comprehensive Cancer Centres (FNCLCC), therefore, has implemented a literature monitoring process.ObjectivesTo identify new data that will likely modify the recommendations set forth in Standards, Options and Recommendations in the Management of Patients with Carcinoma of Unknown Primary Site (2002), evaluate the data’s impact and inform potential users of its validity.MethodsThe monitoring process consists of 3 main steps taken in collaboration with experts: data collection; data selection and classification; and data analysis.ResultsUsing this monitoring process, we identified the need for an update of the recommendations for treating the cervical metastases of an epidermoid carcinoma. All other recommendations in the initial document remain valid (explicit and transparent expert determination).