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PRONOPALL study confirms the three prognostic profiles defined by the combination of four factors. This PRONOPALL score is a useful decision-making tool in daily practice.

Introduction: The cancer incidence continues to rise worldwide. Medical innovation has a major impact on patient survival, but within drug development, it can take more than 10 years to obtain marketing authorisation (MA). The time required for access to therapeutic innovation remains critical, so France has developed a specific expanded access program named ATU, which allows the administration of drugs before the European Medicines Agency (EMA) approval. The purpose of this study is to put in perspective the average time to access antineoplastic drugs worldwide, taking into account ATU, US Food and Drug Administration (FDA) and EMA approvals. Methods: The ATU system allows the use of a medicine before its MA, under exceptional conditions. All antineoplastic drugs in oncology that have benefited from the ATU system are analysed in terms of tumour site, biomarkers and number of patients who have access to the drug. Results: Between 1st January 2007 and 31st December 2019, 36 of 64 drugs (56.2%) that received MA in oncology were assigned an ATU, to the benefit of 16,927 patients. Thanks

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Background: Since 2003, through the impetus given by Pr Erick Gamelin and the Regional Health Agency in Western France (Bretagne, Pays de Loire), a network called OMIT (Drugs and Emerging Therapeutics Observatory) has been created, including the Breast Cancer Forum. Anthracyclins and taxanes are the cornerstones of adjuvant chemotherapy for breast cancer. In France, since the PACS 01 publication1, FEC 100 followed by docetaxel 100 has been the standard adjuvant chemotherapy regimen in breast cancer. Long term toxicities like persistent alopecia or suboptimal hair regrowth have been observed.Methods: Over the last year, the first cases of persistent alopecia or suboptimal hair regrowth after adjuvant chemotherapy have been reported to the Breast Cancer Forum. Consequently, OMIT quickly drew up a case report form and mailed it to every oncologist in Western France to collect data.Results: From May 2008 to April 2009, 66 cases of persistent alopecia or suboptimal hair regrowth after adjuvant chemotherapy from 15 different institutions were declared to OMIT: median age: 60 years (35-78), hypothyroidia: 11, fine hair before treatment: 2. Alopecia was localized: 13, diffuse: 49, complete: 4. The time lapse between the end of chemotherapy and persisting alopecia has been more than 3 months: 5 patients, more than 6 months: 10, more than 12 months: 22, more than 24 months: 29. The chemotherapy regimens were various: schedule FEC (epirubicin 100 mg/msq), 3 courses followed by docetaxel 100 mg/msq, 3 courses: 54, docetaxel 100 mg/msq: 3, TCH (docetaxel-carboplatin-trastuzumab) or TH: 2, FEC 100: 2, epirubicin 75 mg/msq in association with docetaxel 75 mg/msq: 2. Hormonotherapy: letrozole: 13, anastrozole: 18, exemestane: 3, tamoxifene: 14, LH-RH agonist: 3. No hormonotherapy: 13. In some institutions, according to the ECOG trial2, some oncologists quickly decided to change their standard regimen from FEC 100 - docetaxel 100, to EC 100 4 courses followed by weekly paclitaxel for 12 weeks: forthcoming data on persistent alopecia, suboptimal hair regrowth or neuropathy after this ECOG adjuvant chemotherapy regimen will be presented at the symposium.Conclusion: For the first time in France, Western OMIT offers us data about persistent alopecia or suboptimal hair regrowth after adjuvant chemotherapy: it is an important side effect and must be considered by oncologists as optimal information to give to curable patients. The next step is to evaluate the real incidence of this phenomen on the population of patients treated by adjuvant chemotherapy for breast cancer: OMIT is currently working with the Federation Nationale des Centres de Lutte contre le Cancer (FNCLCC) to collect data from prospective trials such as PACS 01 (FEC versus FEC-docetaxel), PACS 04 (FEC versus epirubicin-docetaxel) and PACS 05 (FEC 6 courses versus 4 courses), to create the ALOPACS database.1- Roché H. Sequential Adjuvant Epirubicin-based Regimen and Docetaxel Chemotherapy for node-positive Breast Cancer Patients: the FNCLCC PACS 01 Trial. J Clin Oncol. 2006 dec 20; 24 (36) 5664-71.2- Sparano JA.Weekly Paclitaxel in the Adjuvant Treatment in Breast Cancer. N Engl J Med. 2008 Apr 17; 358(16): 1663-71. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 3174.