ABSTRACT
PURPOSE: The use of oral cancer drugs (OAD) has increased over the last two decades. The objective of this study was to measure the impact of a nurse-led telephone follow-up in the therapeutic management of patients treated with an OAD regarding toxicity, medication adherence and quality of life. METHODS: A randomized, multicenter, controlled trial was conducted. All consecutive over 18-year-old patients, treated in medical oncology, radiotherapy, or hematology departments, receiving OAD for any cancer were invited to participate to the study. A total of 183 patients treated for solid or hematological cancers with an OAD were randomly assigned to receive a nurse-led telephone follow-up or standard care for 24 weeks. Data were collected between 2015 and 2018. RESULTS: Nurse telephone follow-up did not improve the global score toxicity in the intervention group. However, telephone calls directed by trained nurses induced a significant decrease in number of patients with grade 3 adverse events throughout the follow-up [OR 0.45 (IC à 95%) (0.23, 0.9)](P = 0.03). There was no significant difference in quality of life and medication adherence between groups at any follow-up time point. CONCLUSIONS: In this first French real-life study, the advice provided by qualified nurses via phone calls improved the management of grade 3 toxicities but failed to demonstrate an improvement of all grades of toxicities. More prospective studies are needed to confirm the impact of telephone calls on the toxicities related to OAD. TRIAL REGISTRATION: Clinical trial registration is NCT02459483. Protection committee SUD-ESTI registration is 2015-A00527-42 on 13 April 2015. National Agency for the Safety of Medicines and Health Products registration is 150619-B on the 27 may 2015.
Subject(s)
Antineoplastic Agents/therapeutic use , Medication Adherence/psychology , Quality of Life/psychology , Aged , Antineoplastic Agents/pharmacology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective StudiesABSTRACT
Bladder cancer (urothelial carcinoma in 90 % of cases) is the most common neoplasia of the urinary tract. Superficial carcinoma represents 70-80 % of bladder cancers. The treatment of these tumours includes, after transuretral resection, intravesical Bacillus Calmette-Guerin (BCG) instillation therapy. This treatment constitutes, by its immune-mediated anti-tumoral action, the first step of immunotherapy in cancer. Severe complications (granulomatosis, hypersensitivity pneumonitis or orchitis) are rare (0.5-2 %). Here we report a complex case of pulmonary granulomatosis secondary to BCG therapy. This is a 74-year-old male, treated for superficial bladder carcinoma by transuretral resection (pT1G3) and then endovesical instillations of BCG therapy for two months. Two years later, a new transuretral resection shows an infiltrating urothelial carcinoma pT2G3. The extension balance finds a persistent micro-nodular pulmonary infiltrate. A broncho-alveolar lavage is then realised but no mycobacteria was found. A surgical biopsy of a nodule is performed and revealed a histiocytic reaction without any neoplastic element. Detection of Mycobacterium tuberculosis by Polymerase Chain Reaction (PCR) was finally positive. In the absence of a secondary lesion, the patient had a cysto-prostatectomy and began a tritherapy against tuberculosis. Post-BCG therapy granulomatosis is a rare complication but should remain a differential diagnosis in front of the appearance of pulmonary nodes in patients who have received posttransuretral resection BCG instillations. Mycobacterial DNA PCR research remains the most sensitive examination.
Les carcinomes urothéliaux superficiels de vessies représentent 70 à 80 % des tumeurs de la vessie. Leur traitement comprend, après résection transurétrale, une BCG (Bacille de Calmette et Guérin) thérapie par instillations endovésicales. Les complications sévères (granulomatose, pneumopathie d'hypersensibilité ou orchite) sont rares (0,5-2 %) mais nous rapportons ici un cas complexe de granulomatose pulmonaire secondaire à une BCG thérapie. Il s'agit d'un homme de 74 ans, traité pour un carcinome urothélial superficiel de vessie par résection endo-urétrale (pT1G3) puis instillations endovésicales de BCG thérapie. Deux années après, une nouvelle résection transurétrale objective un carcinome urothélial infiltrant pT2G3. Le bilan d'extension retrouve un infiltrat pulmonaire micronodulaire persistant. Un lavage bronchoalvéolaire ne retrouve pas de bacilles acido-alcoolo-résistants. La biopsie chirurgicale d'un nodule retrouve une réaction histiocytaire sans élément néoplasique. La Polymerase Chain Reaction (PCR) à la recherche de mycobactérie du groupe tuberculosis revient finalement positive. En l'absence de lésion secondaire, le patient a bénéficié d'une cystoprostatectomie et a débuté dans les suites une trithérapie antituberculeuse. La granulomatose post-BCG thérapie est une complication rare, mais doit rester un diagnostic différentiel devant l'apparition de micronodules pulmonaires chez les patients ayant reçu des instillations de BCG post-résection transurétrale. La recherche par PCR d'ADN de mycobactéries reste l'examen le plus sensible.
