Maintenance monotherapy with gemcitabine after standard platinum‐based chemotherapy in patients with advanced urothelial cancer

Abstract

Objectives: To investigate the outcomes of gemcitabine maintenance monotherapy treatment for metastatic urothelial cancer. Methods: Gemcitabine maintenance monotherapy was used for metastatic urothelial cancer patients after standard platinum-based chemotherapy. A standard dose of 1000 mg/m 2 /month was given. If patients suffered adverse events or a noticeably compromised quality of life, treatment intervals were extended and doses lowered. Patients with metastatic urothelial cancer receiving only best supportive care after standard chemotherapy served as the retrospective control group. Results: A total of 33 patients were included in the study group as well as in the control group. Maintenance therapy was administered a median of nine times (range 2-49 times) with a median dose of 984.2 mg (range 500-1400 mg) per time. An adverse event of the Common Terminology Criteria of Adverse Events grade 3 or greater was observed in 10 (30.3%) patients, while nine patients (27.3%) experienced hematotoxicity. After standard chemotherapy pretreatment, disease-specific survival in the maintenance therapy group was an average of 15.0 months, significantly more favorable (P < 0.001) than that of the control group (4.0 months). On multivariate analysis, efficacy of prior chemotherapy (P = 0.018), visceral metastasis (P = 0.007) and gemcitabine maintenance therapy (P < 0.001) were statistically significant prognostic parameters of disease-specific survival. Conclusion: The present study findings suggest that gemcitabine maintenance monotherapy in metastatic urothelial cancer might not only be useful as a palliative treatment, but it could also have a certain level of therapeutic effectiveness.

Maintenance treatment with gemcitabine have a promising activity on metastatic bladder cancer survival

“…Seventy-nine percent of patients presented with stable disease, and 8% of the patients demonstrated disease regression after the main chemotherapy. Different from Muto et al [27] study and our study, presence of visceral metastasis was not identified as a prognostic factor in this study. In this regard, gemcitabine maintenance treatment after surgical treatment modality was used in two studies, which prolonged the survival.…”

“…The treatment break for patients who responded to first-line therapy is generally shortterm for about 2 to 3 months and it leads to rapid clinical progression and deterioration. [27] Moreover, clinical deterioration might not allow usage of second-line therapy in such patients. In this regard, chance of extended response and safe treatment with maintenance treatment should not be missed out.…”

“…We showed that administering gemcitabine provided a delayed disease progression with a low toxicity profile consistent with the results of limited number of similar studies. [27,29] Gemcitabine maintenance treatment is also a valuable agent for the patients with squamous cell lung cancer who responded to platinum-gemcitabine chemotherapy. However, despite the improvement in PFS with gemcitabine, according to some studies this PFS advantage did not reflect on OS.…”

“…Muto et al [27] compared gemcitabine maintenance treatment and placebo in patients with urothelial carcinomas who received MVAC or GC as the first-line therapy. The patients had lung (36%), liver (36.4%) and bone (27.3%) metastases.…”

Maintenance monotherapy with Gemcitabine following cisplatin-based primary combination chemotherapy in surgically treated advanced urothelial carcinoma: A matched-pair single institution analysis

“…GEM monotherapy has been assessed in specific solid and haematological cancers (10)(11)(12) and, although no established maintenance therapy for UC is available at present, predominantly Japanese researchers have gained experience in this cancer entity with GEM monotherapy, demonstrating comparably low, although potentially promising response rates when used as a monotherapy alone, Following primary CBCC, a novel study published by Muto et al (7) demonstrated that GEM appeared to have a prognostic benefit in an UC patient collective (n=33) of palliative, non-surgically treated patients. The authors showed marked advantages in the maintenance group with respect to CSS and PFS rates compared with a control group receiving best supportive care alone, accompanied by a low rate of adverse events.…”