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. 2017 Aug 15;5(1):68.
doi: 10.1186/s40425-017-0271-0.

Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of bladder carcinoma

Ashish M Kamat  1 , Joaquim Bellmunt  2 , Matthew D Galsky  3 , Badrinath R Konety  4 , Donald L Lamm  5 , David Langham  6 , Cheryl T Lee  7 , Matthew I Milowsky  8 , Michael A O'Donnell  9 , Peter H O'Donnell  10 , Daniel P Petrylak  11 , Padmanee Sharma  12 , Eila C Skinner  13 , Guru Sonpavde  14 , John A Taylor 3rd  15 , Prasanth Abraham  12 , Jonathan E Rosenberg  16
Affiliations

Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of bladder carcinoma

Ashish M Kamat et al. J Immunother Cancer. .

Erratum in

Abstract

The standard of care for most patients with non-muscle-invasive bladder cancer (NMIBC) is immunotherapy with intravesical Bacillus Calmette-Guérin (BCG), which activates the immune system to recognize and destroy malignant cells and has demonstrated durable clinical benefit. Urologic best-practice guidelines and consensus reports have been developed and strengthened based on data on the timing, dose, and duration of therapy from randomized clinical trials, as well as by critical evaluation of criteria for progression. However, these reports have not penetrated the community, and many patients do not receive appropriate therapy. Additionally, several immune checkpoint inhibitors have recently been approved for treatment of metastatic disease. The approval of immune checkpoint blockade for patients with platinum-resistant or -ineligible metastatic bladder cancer has led to considerations of expanded use for both advanced and, potentially, localized disease. To address these issues and others surrounding the appropriate use of immunotherapy for the treatment of bladder cancer, the Society for Immunotherapy of Cancer (SITC) convened a Task Force of experts, including physicians, patient advocates, and nurses, to address issues related to patient selection, toxicity management, clinical endpoints, as well as the combination and sequencing of therapies. Following the standard approach established by the Society for other cancers, a systematic literature review and analysis of data, combined with consensus voting was used to generate guidelines. Here, we provide a consensus statement for the use of immunotherapy in patients with bladder cancer, with plans to update these recommendations as the field progresses.

Keywords: Bladder cancer; Consensus statement; Guidelines; Immunotherapy.

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Conflict of interest statement

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Not applicable.

Consent for publication

Not applicable.

Competing interests

AMK has received research support from NCI, FKD Industries, Photocure, Merck, and Heat Biologics. In addition, he has served on advisory boards or review panels for Photocure, Sanofi, Merck, Abbot Molecular, Theralase, Heat Biologics, Spectrum Pharmaceuticals, Pacific Edge, Astra Zeneca, Genentech, Pfizer and Oncogenix. JB has served as a consultant or on advisory boards for Genentech (Roche), Pfizer, and AstraZeneca. MDG has served on advisory boards for Genentech (Roche), EMD Serono, AstraZeneca, and Astellas. BRK has received research support from Spectrum Pharmaceticals, Genomic Health, Photocure, Heat Biologics, and FKD Industries. MIM has received research support from Mirati Therapeutics, Pfizer, Cerulean Pharma, Merck, Seattle Genetics, Acerta Pharma, BioClin Therapeutics, Genentech (Roche), Bristol-Myers Squibb, X4 Pharma, MedImmune, Incyte, Innocrin Pharma, and Inovio Pharmaceuticals. MAO has served on advisory boards for Genentech (Roche), AstraZeneca, Inovio Pharmaceuticals, and Novartis. PHO has participated on advisory boards or has acted as a consultant to Bayer, Bellicum, Dendreon, Sanofi Aventis, Medivation, Pfizer, Roche Laboratories, Ferring, Johnson and Johnson, Exelixis, and Millennium. He has also received research support from Oncogenix, Progenics, Johnson and Johnson, Merck, Millennium, Dendreon, Sanofi Aventis, Eli Lilly, and Roche Laboratories and owns stock in Bellicum Pharmaceuticals and Tyme Technologies. PS has acted as a consultant to or on an advisory board for Bristol-Myers Squibb, Glaxo-Kline Smith, AstraZeneca, Amgen, Constellation, Jounce, Kite Pharma, Evelo, Neon, and EMD Serono and owns stock in Jounce, Kite Pharma, Evelo, Neon, and Constellation. Her spouse also owns patents licensed to Jounce, Merck, and Bristol-Myers Squibb. GS has acted as a consultant to Bayer, Sanofi, Pfizer, Novartis, Eisai, Janssen, Amgen, Astrazeneca, Merck, Genentech (Roche), Argos, and Agensys, and he has participated as a speaker for Clinical Care Options and has acted as an author for UpToDate. In addition, he has received research support from Bayer, Onyz, Celgene, Boehringer Ingelheim, and Merck. JER has acted as a consultant to Merck, Bristol-Myers Squibb, Eli Lilly, Agensys, Genentech (Roche), Sanofi, EMD Serono, AstraZeneca, Innovio, Seattle Genetics, Oncogenex, and Bayer. In addition, he also owns stock in Merck and Illumina. DLL, JAT, PA, CTL, and ES declare that they have no competing interests to disclose.

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Figures

Fig. 1
Fig. 1
Treatment algorithm for non-muscle invasive bladder cancer. All of the treatment options shown may be appropriate. The selection of therapy should be individualized based on patient eligibility and the availability of the therapy at the discretion of the treating physician. These algorithms are meant to provide advice as the consensus recommendations of the Task Force. (1) The Task Force defines Low Risk as solitary, primary low-grade Ta tumor. (2) Intermediate Risk is defined as histologically-confirmed multiple and/or recurrent low-grade Ta tumors. (3) High risk is defined as any T1, high-grade and/or carcinoma in situ
Fig. 2
Fig. 2
Sample template to provide to patients to record BCG treatment/cystoscopy dates
Fig. 3
Fig. 3
All of the treatment options shown may be appropriate. The selection of therapy should be individualized based on patient eligibility and the availability of therapy, at the discretion of the treating physician. These algorithms represent the consensus recommendations of the Task Force. (1) Atezolizumab and pembrolizumab are FDA approved for patients with metastatic urothelial carcinoma who are ineligible to receive cisplatin. (2) Atezolizumab, nivolumab, durvalumab, avelumab, and pembrolizumab are FDA approved for advanced disease that has worsened on platinum containing regimens or within 12 months of receiving a platinum-containing regimen before (neoadjuvant) or after surgery (adjuvant). Abbreviations: dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (DDMVAC)
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