[Quality insurance system establishment in the management of home-based chemotherapy: example of hospital at home "Assistance publique-Hôpitaux de Paris"]. / Mise en place d'un système d'assurance-qualité dans la prise en charge des chimiothérapies à domicile : exemple de l'hospitalisation à domicile « Assistance publique-Hôpitaux de Paris ¼

While home-based chemotherapy improves comfort and quality of life of patients, quality and safety conditions must be equivalent to hospital settings. In addition, organization is much more complex. At the hospital at home "Assistance publique-Hôpitaux de Paris", prescribers are potentially spread across 21 health facilities. The administration of chemotherapy is performed by about 300 nurses at the patient's home in Paris and its suburbs. Centralized preparations of chemotherapy began in September 2009 by the pharmacy department of Georges-Pompidou European hospital, with a progressive increase of the activity. This article describes the quality insurance system established with this new organization to meet the specific challenges of home therapy: choice of eligible anticancer drugs, computerized information systems and networking with other heath facilities, secure transport conditions, traceability from the prescription to the administration, security of administration. This experience can offer an important support for other centres in their approach of quality insurance for home chemotherapy.

The addition of cisplatin to cyclophosphamide-doxorubicin-etoposide combination chemotherapy in the treatment of patients with small cell lung carcinoma: A randomized study of 457 patients. "Petites Cellules" Group.

BACKGROUND: To assess whether the addition of cisplatin (100 mg/m(2) administered intravenously on Day 1) to CDE (cyclophosphamide [1000 mg/m(2) on Day 1], doxorubicin [45 mg/m(2) on Day 1], and etoposide [150 mg/m(2) on Days 1 and 2] combination is useful in the treatment of patients with small cell lung carcinoma (SCLC). METHODS: In a multicenter clinical trial, 457 patients were randomized from May 1988 to March 1993 to receive either CDE (n = 228) or cisplatin-CDE (PCDE, n = 229) chemotherapy every 4 weeks for 6 cycles. As patients with limited SCLC were included in a concomitant trial assessing thoracic radiotherapy, the current study mainly included patients with extensive stage (79%) or limited stage disease and a contraindication for thoracic radiotherapy. RESULTS: The objective response rate was higher in the cisplatin-CDE group (72%) than in the CDE group (53%) (P = 0.0001). The median overall survival was similar for the groups that received CDE (266 days) and PCDE (271 days) (P = 0.93, log rank test). A higher fatal neutropenia rate was observed in the PCDE group (n = 23) than in the CDE group (n = 4) (P < 0.001, log rank test), mainly for patients with extensive disease (n = 26; P = 0.015, log rank test). CONCLUSIONS: The addition of cisplatin to a CDE regimen is toxic to patients with extensive SCLC and does not improve overall survival. The PCDE combination must be avoided for patients with extensive SCLC; CDE or cisplatin-etoposide combinations remain standard chemotherapy for these patients. The PCDE combination associated with granulocyte-colony stimulating factors could only be assessed in patients with good prognoses.

Two cycles of cisplatin-vindesine and radiotherapy for localized nonsmall cell carcinoma of the lung (stage III). Results of a prospective trial with 149 patients.

One hundred forty-nine patients with localized nonsmall cell carcinoma of the lung (Stage III A and B) were treated with two monthly cycles of initial chemotherapy that included vindesine-cisplatin followed by 6000 cGy of thoracic irradiation. Patients with complete, partial, and minor response after initial chemotherapy were randomized into groups to receive either maintenance chemotherapy (four cycles) after radiotherapy or radiotherapy alone. The objective response rate was 24% after chemotherapy and 41% after combined chemoradiotherapy (complete response, 7.5%). The overall median survival was 9 months and the 2-year survival was 14%. Survival was identical with or without maintenance chemotherapy. The 2-year survival of patients with complete response was 75% compared with 9% for patients with partial or minor response. These results suggest that only the few patients (ten) who achieve complete response have a strong probability of survival. It is therefore essential to search for other therapeutic modalities that result in an increase of the complete response rate.

Cisplatin and vindesine for disseminated non-small cell lung cancer. Results of a prospective trial with 81 patients.

Eighty-one patients with disseminated non-small cell lung cancer (stage IV) were treated with 2 monthly cycles of initial chemotherapy combining cisplatin with vindesine. The initial chemotherapy-responding patients (CR, PR, MR) were randomized to 2 cycles or 4 cycles of maintenance chemotherapy. After initial chemotherapy, the response rate was 33% (CR, PR, MR) with 18.5% objective responses. The overall 1-year survival rate was 15% with 37% for responders as opposed to 2% for non-responders. Maintenance chemotherapy did not improve the response rate obtained after initial cycles. The small number of patients does not allow us to reach a definite conclusion on the optimum duration of maintenance chemotherapy. In the absence of large placebo versus chemotherapy randomized trials, no definite conclusion can be made on the benefit of chemotherapy in disseminated non-small cell lung cancer. This study suggests, however, that chemotherapy is associated with a significantly longer survival in responding patients.