Randomized Phase III Trial on Gemcitabine Versus Mytomicin in Recurrent Superficial Bladder Cancer: Evaluation of Efficacy and Tolerance

Addeo, Raffaele; Caraglia, Michele; Bellini, Sergio; Abbruzzese, Alberto; Vincenzi, Bruno; Montella, Liliana; Miragliuolo, Antonio; Guarrasi, Rosario; Lanna, Michele; Cennamo, Gregorio; Faiola, Vincenzo; Prete, Salvatore Del

doi:10.1200/jco.2008.20.8199

Cited by 165 publications

(99 citation statements)

References 29 publications

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“…No patients in this study developed disease progression. Additionally, Addeo et al [18] , compared 6-week course of GEM with 4-week course of MMC in an RCT. Responders of the induction therapy further received maintenance therapy consisting of 10-monthly MMC treatments.…”

Section: Gemcitabinementioning

confidence: 99%

Alternative therapies in patients with non-muscle invasive bladder cancer

Şanlı

Lotan

2017

Turkish Journal of Urology

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Bladder cancer (BC) is one of the leading causes of cancer-related deaths worldwide. Despite, the majority of the cases were diagnosed as non-muscle invasive bladder cancer (NMIBC) with favorable prognosis, it has tendency to recur or progress to a higher grade or stage. The first line treatment of patients with NMIBC is transurethral resection with adjuvant therapies primarily intravesical Bacillus Calmette-Guérin (BCG) immunotherapy. However, in a portion of patients whose BCG treatment failed, alternative treatments may be required. Furthermore, intravesical BCG may be contraindicated in or untolerated by a group of patients. For these patients, some treatment options are readily available and a variety of them are currently under clinical investigation. In this review, these alternative therapies have been summarized.

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Section: Gemcitabinementioning

confidence: 99%

Alternative therapies in patients with non-muscle invasive bladder cancer

Şanlı

Lotan

2017

Turkish Journal of Urology

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“…Many experimental modalities are now available for treating patients with superficial bladder cancer and optimized chemotherapy with MMC and GEM have shown some encouraging results (4). In a recent study by Addeo et al (16), the comparison of GEM and MMC shows that GEM has a better chemopreventive activity than MMC. The percentage of patients with recurrence on intravesical chemotherapy for GEM significantly differs from that observed in MMC-treated patients.…”

Section: Discussionmentioning

confidence: 99%

Chondroitin sulphate enhances the antitumor activity of gemcitabine and mitomycin-C in bladder cancer cells with different mechanisms

et al. 2011

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Abstract. Non-muscle invasive bladder cancer is the most common type of bladder cancer in Western countries. The glycosaminoglycan (GAG) layer at the bladder surface non-specifically blocks the adherence of bacteria, ions and molecules to the bladder epithelium and bladder cancer cells express CD44 that binds GAG. Currently, there are few options other than cystectomy for the management of non-muscle invasive bladder cancer with intravesical chemotherapy using several drugs such as gemcitabine (GEM) and mitomycin-C (MMC) with poor prophylactic activity. In this study, we investigated the effects of the GAG chondroitin sulphate (CS) on the growth inhibition of human bladder cancer cell lines HT-1376 and effects of the combination between GEM or MMC with CS. We have found that CS, MMC and GEM induced 50% growth inhibition at 72 h. Therefore, we have evaluated the growth inhibition induced by different concentration of CS in combination with MMC or GEM, respectively, at 72 h. We have observed, at Calcusyn analysis, a synergism when HT-1376 cells were treated with CS in combination with MMC or GEM, respectively, if used at an equimolar ratio. We have also found that CS/GEM combination induced a strong potentiation of apoptosis with the consequent activation of caspases 9 and 3. On the other hand, HT-1376 cells were necrotic if exposed to the CS/MMC combination and no signs of caspase activation was observed.In conclusion, in the human bladder cancer cell line HT-1376 pharmacological combination of CS with GEM or MMC resulted in a strong synergism on cell growth inhibition. IntroductionNon-muscle invasive bladder cancer is the most common type of bladder cancer in Western countries. There are multiple risk factors for bladder cancer, which include exposure to tobacco and industrial chemicals, ingestion of arsenic-laced water, radiation therapy to organs adjacent to the bladder, therapeutic use of alkylating agents in chemotherapy regimens, and infection with the trematode Schistosoma haematobium. The glycosaminoglycan layer at the bladder surface non-specifically blocks the adherence of bacteria, ions and molecules to the epithelium. Therefore, it may be an important element in the first line of defence against infection, calculi and even carcinogens for the transitional cells of the bladder. Qualitative or quantitative defects in the glycosaminoglycan(s) expression may influence an individual's susceptibility to the development of bladder tumors (1-3).At initial presentation 70% of bladder cancers are superficial and include carcinoma in situ (CIS), Ta, and T1 disease. Transurethral resection (TUR) is the primary mode of clinical management for both diagnosis and treatment of superficial bladder cancer, but 60 to 70% of these cancers recur and 20% progress to a higher stage (4). TUR is commonly followed by intravesical infusion of either chemotherapy or immune-modulating agents in order to reduce the incidence of recurrence and progression. Bacille Calmette-Guèrin (BCG) is the most effective agent in the prevention ...

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“…80 By contrast, intravesical gemcitabine is particularly active in patients with intermediate risk papillary disease in whom BCG treatment has failed, even demonstrating superiority in comparison with mitomycin. 81,82 However, two studies of gemcitabine in BCGrefractory disease resulted in 2year durable responses of only 7% and 21%.…”

Section: Options After Bcg Failurementioning

confidence: 99%

Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer

et al. 2015

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| Multiple clinical trials have demonstrated that intravesical Bacillus Calmette-Guérin (BCG) treatment reduces recurrences and progression in patients with non-muscle-invasive bladder cancer (NMIBC). However, although BCG has been in use for almost 40 years, this agent is often underutilized and practice patterns of administration vary. This neglect is most likely caused by uncertainties about the optimal use of BCG, including unawareness of optimal treatment schedules and about patient populations that most benefit from BCG treatment. To address this deficit, a focus group of specialized urologic oncologists (urologists, medical oncologists and radiation oncologists) reviewed the current guidelines and clinical evidence, discussed their experiences and formed a consensus regarding the optimal use of BCG in the management of patients with NIMBC. The experts concluded that continuing therapy with 3-week BCG maintenance is superior to induction treatment only and is the single most important factor in improving outcomes in patients with NMIBC. They also concluded that a reliable alternative to radical cystectomy in truly BCG-refractory disease remains the subject of clinical trials. In addition, definitions for common terms of BCG failure, such as BCG-refractory and BCG-intolerant, have been formulated.

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Randomized Phase III Trial on Gemcitabine Versus Mytomicin in Recurrent Superficial Bladder Cancer: Evaluation of Efficacy and Tolerance

Abstract: This study demonstrates that GEM has better efficacy and lower toxicity than MMC; therefore, GEM appears as a logical candidate for intrabladder therapy in patients with refractory transitional cancer.

Cited by 165 publications

References 29 publications

Alternative therapies in patients with non-muscle invasive bladder cancer

Alternative therapies in patients with non-muscle invasive bladder cancer

Chondroitin sulphate enhances the antitumor activity of gemcitabine and mitomycin-C in bladder cancer cells with different mechanisms

Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer

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