Prospective Multicenter Phase II Study of Gemcitabine Plus Platinum Salt for Metastatic Collecting Duct Carcinoma: Results of a GETUG (Groupe d’Etudes des Tumeurs Uro-Génitales) Study

Oudard, Stéphane; Banu, E.; Vieillefond, Annick; Fournier, Laure; Priou, Franck; Médioni, Jacques; Banu, A.; Duclos, B.; Rolland, Frédéric; Escudier, Bernard; Arakelyan, Nina; Culine, Stéphane

doi:10.1016/j.juro.2007.01.063

Cited by 174 publications

(124 citation statements)

References 16 publications

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“…In keeping with the recent study by Oudard et al 11 , cdc tumours may be treated systemically with cytotoxic therapy, as in urothelial carcinoma. Accordingly, patients 2 and 3 received mvac, a standard of care in metastatic urothelial carcinoma 39,40 .…”

Section: Case Seriessupporting

confidence: 70%

“…Surgery Almost all reported patients with cdc have undergone surgery [1][2][3]11 and are diagnosed with cdc only after a histopathology examination. To illustrate this point, 87% of patients in the study by Oudard et al underwent prior cytoreductive nephrectomy.…”

Section: 21mentioning

confidence: 99%

“…For example, Mejean et al 23 reported 3 perioperative deaths in their series of 10 patients undergoing surgery for cdc. Surgical complications and recovery may also delay or prevent a patient from receiving systemic therapy 11 . Accordingly, surgical therapy for known cdc must be individualized.…”

Section: 21mentioning

confidence: 99%

“…The study by Oudard et al 11 was the highest quality study, in that it was a prospective phase ii trial with central histopathology review (level of evidence: 2b). Limitations of that study were discussed.…”

Section: Quality Of Available Evidencementioning

confidence: 99%

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Management of Renal Collecting Duct Carcinoma: A Systematic Review and the McMaster Experience

et al. 2013

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Introduction: Collecting duct carcinoma (CDC) is a rare, aggressive form of renal carcinoma that presents at an advanced stage and has a poor prognosis. Little is known concerning the optimal management of CDC. We present the results of a systematic review addressing the management of CDC and the McMaster University CDC series. Methods: The MEDLINE, Cochrane Library, and EMBASE databases and conference proceedings were searched to identify studies relating to the management of CDC. Included studies reported on a minimum of 10 subjects receiving a single intervention. Series in which an evaluation of therapeutic effectiveness was not possible were excluded. The McMaster University (Hamilton, Ontario) series of 6 cases of CDC were retrospectively reviewed. Results: We identified 3 studies relevant to the management of CDC that included a total of 72 patients. A gemcitabine–cisplatin or –carboplatin regimen resulted in a 26% objective response rate in 23 patients with metastatic CDC. Two additional studies indicated that 49 patients treated with immunotherapy achieved no response. In the McMaster series, cytoreductive nephrectomy was performed in 4 of 6 patients. In 2 patients, MVAC therapy (methotrexate–vinblastine–doxorubicin–cisplatin) achieved no response. No significant therapeutic complications occurred, but survival was poor (median: 11 months; range: 10–33 months). Conclusions: Our review and clinical experience suggest that the current standard of care for metastatic CDC is a gemcitabine–cisplatin regimen.

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Section: Case Seriessupporting

confidence: 70%

Section: 21mentioning

confidence: 99%

Section: 21mentioning

confidence: 99%

Section: Quality Of Available Evidencementioning

confidence: 99%

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Management of Renal Collecting Duct Carcinoma: A Systematic Review and the McMaster Experience

et al. 2013

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“…В многоцентровом исследовании II фазы изучали эффективность комбинации гемцитабина с препара-тами платины у больных раком из собирательных тру-бочек [52]. Гемцитабин назначали внутривенно в 1-й и 8-й дни в дозе 1250 мг / м 2 , цисплатин 70 мг / м 2 или карбоплатин (AUC5) -в 1-й день цикла.…”

Section: химиотерапияunclassified

Current treatment approach to non-clear cell renal carcinoma

Тимофеев¹

2015

Cancer Urology

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Cabozantinib as First-line Treatment in Patients With Metastatic Collecting Duct Renal Cell Carcinoma

et al. 2022

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IMPORTANCE Metastatic collecting duct carcinoma (mCDC) is a rare type of non-clear cell renal cell carcinoma (ncRCC) with poor prognosis and no standard treatments. Despite retrospective series that have documented the benefit of cabozantinib in ncRCC, no prospective trials have evaluated this treatment in mCDC.OBJECTIVE To determine whether cabozantinib is an active treatment in patients with mCDC. DESIGN, SETTING, AND PARTICIPANTSThe caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI) trial was an open-label, single-arm, phase 2 clinical trial carried out between January 2018 and November 2020 at a single academic center with data cut off in September 2021 on behalf of the the Italian Network for Research in Urologic-Oncology (Meet-URO 2). Eligible patients had histologic diagnosis of centrally confirmed mCDC with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1). In total, 25 patients were screened.INTERVENTIONS Patients received cabozantinib, 60 mg orally once daily, until disease progression, unacceptable toxic effects, or withdrawal of consent. MAIN OUTCOMES AND MEASURESThe primary end point was objective response rate (ORR) per RECIST, version 1.1.RESULTS At data cut off, of 25 patients enrolled, 23 started treatment because 2 were excluded after failing the screening process at pathologic review. The median follow-up cannot be estimated using the reverse Kaplan-Meier estimator. The median time to censoring was 11 months (95% CI, 0-22 months). Median (range) age was 66 (53-74) years. As best overall response, 3 patients presented stable disease, 1 patient achieved a complete response, and 7 a partial response. The ORR was 35% (95% CI, 16%-57%). The median progression-free survival was 4 months (95% CI, 3-13 months). The median OS was 7 months (95% CI, 3-31 months). All patients reported at least 1 grade (G) 1 to 2 adverse event (AE). The most common G1 to G2 AEs were fatigue (14 [60%]), anorexia (9 [39%]), hand-foot syndrome (7 [30%]), hypothyroidism (7 [30%]), mucositis (7 [30%]), diarrhea (5 [22%]), and hypertension (3 [13%]). Six G3 AEs were reported: 2 arterial hyperthension, 1 pulmonary thromboembolism, 1 bleeding, and 2 fatigue. There were no permanent discontinuations from the study owing to AEs. Four patients (17%) required dose reduction to 40 mg, and 4 (17%) required a transitory interruption to manage toxic effects. CONCLUSIONS AND RELEVANCEThe study met the ORR primary end point, showing encouraging efficacy of cabozantinib in untreated patients with mCDC. Further investigations to advance the molecular understanding of this tumor are ongoing.

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Prospective Multicenter Phase II Study of Gemcitabine Plus Platinum Salt for Metastatic Collecting Duct Carcinoma: Results of a GETUG (Groupe d’Etudes des Tumeurs Uro-Génitales) Study

Cited by 174 publications

References 16 publications

Management of Renal Collecting Duct Carcinoma: A Systematic Review and the McMaster Experience

Management of Renal Collecting Duct Carcinoma: A Systematic Review and the McMaster Experience

Current treatment approach to non-clear cell renal carcinoma

Cabozantinib as First-line Treatment in Patients With Metastatic Collecting Duct Renal Cell Carcinoma

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