RTOG 97-06: Initial report of a Phase I–II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with cisplatin, and adjuvant MCV combination chemotherapy

Hagan, Michael P.; Winter, Kathryn; Kaufman, Donald S.; Wajsman, Zev; Zietman, Anthony L.; Heney, N.M.; Toonkel, Leonard M.; Jones, Christopher U.; Roberts, John D.; Shipley, William U.

doi:10.1016/s0360-3016(03)00718-1

Cited by 190 publications

(118 citation statements)

References 23 publications

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“…The survival rates obtained in this study were similar to the rates reported in the literature [1,2,4,5,6]. Importantly, these survival rates were obtained despite the significantly higher rate of older patients (54% of patients older than 70 years) and the comorbid conditions (30 patients judged unfit for radical cystectomy).…”

Section: Discussionsupporting

confidence: 88%

“…Patients who are too sick to safely undergo surgery or who are unwilling to accept the morbidity of surgery select alternative treatment with chemo-radiation therapy. Several larger phases II-III studies of chemo-radiation therapy series compare favorably to results reported by primary cystectomy (with or without adjuvant therapy) with 60% to 70% of complete response after chemo-radiation [1][2][3][4] and 3-year overall survival at 40%-50% [2,4,5,6]. Further 75% of the patients achieved cure with maintained bladder function [7,8].…”

Section: Introductionmentioning

confidence: 77%

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Bladder-Preservation Therapy in Muscle-Invasive Bladder Cancer: A Single Centre Experience

Bourhafour¹,

Elallam²,

Elalami³

et al. 2016

IOSR

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(6%), 21 (46%), 7 (15%) and 15 (33%) for T1, T2, T3 and T4, respectively. Treatment consisted in a transurethral resection of bladder tumor as complete as feasible followed by curative concurrent chemoradiation. Results:Twenty-nine patients showed complete response (CR), 22 of whom (48%) had a continuously tumor free bladder. With a median follow-up of 30 months (12-92 months), the 3-year overall survival (OS) was 50%; Local recurrence-free survival (LRFS) was 59% at 3 years and the distant metastases free survival (MFS) was

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Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 77%

Bladder-Preservation Therapy in Muscle-Invasive Bladder Cancer: A Single Centre Experience

Bourhafour¹,

Elallam²,

Elalami³

et al. 2016

IOSR

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“…52 The subsequent RTOG 95-06 trial treated 34 patients with twice-daily irradiation and concurrent cisplatin and 5-FU and reported a 3-year OS rate of 83%. 57 In the RTOG 97-06 trial, 47 patients received twice-daily irradiation and concurrent cisplatin, and also received adjuvant chemotherapy with CMV 58 ; the 3-year OS rate was 61%. In the RTOG 99-06 study, 80 patients received twice-daily irradiation plus cisplatin and paclitaxel, followed by adjuvant cisplatin and gemcitabine; the 5-year OS rate was 56%.…”

Section: Rt With Concurrent Chemotherapy Followingmentioning

confidence: 99%

“…[51][52][53][54][55][56][57][58][59] A combined analysis of survivors from these 4 trials, with a median follow-up of 5.4 years, showed that combined-modality therapy was associated with low rates of late grade 3 toxicity (5.7% genitourinary and 1.9% gastrointestinal). 61 No late grade 4 toxicities or treatment-related deaths were recorded.…”

Section: Rt With Concurrent Chemotherapy Followingmentioning

confidence: 99%

Bladder Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Spiess¹,

Agarwal²,

Bangs³

et al. 2017

J Natl Compr Canc Netw

228

173

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OverviewAn estimated 79,030 new cases of urinary bladder cancer (60,490 men and 18,540 women) will be diagnosed in the United States in 2017 and approximately 16,870 deaths (12,240 men and 4630 women) will occur. Please NoteThe NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines Disclosures for the NCCN Bladder Cancer PanelAt the beginning of each NCCN Guidelines panel meeting, panel members review all potential conflicts of interest. NCCN, in keeping with its commitment to public transparency, publishes these disclosures for panel members, staff, and NCCN itself.Individual disclosures for the NCCN Bladder Cancer Panel members can be found on page 1267 (The most recent version of these guidelines and accompanying disclosures are available on the NCCN Web site at NCCN.org.)These guidelines are also available on the Internet. For the latest update, visit NCCN.org.

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“…Trimodality therapy consisting of radical transurethral resection, chemotherapy and radiation therapy has been attempted as an alternative approach for patients who require cystectomy. Data from multiple institutional and cooperative group studies have shown that this approach is safe and effective, yielding a complete response (CR) in more than 60% of cases (9)(10)(11)(12)(13)(14)(15). However, prospective protocols conducted by the Radiation Therapy Oncology Group (RTOG) demonstrated a survival rate similar to that for radical cystectomy; none of the protocols achieved a 5-year survival rate of more than 60% (9-13).…”

Section: Introductionmentioning

confidence: 99%

Novel bladder preservation therapy for locally invasive bladder cancer: Combined therapy using balloon-occluded arterial infusion of anticancer agent and hemodialysis with concurrent radiation

Azuma

Inamoto²,

Ibuki³

et al. 2010

Int J Oncol

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Abstract.We investigated the effect of balloon-occluded arterial infusion (BOAI) of anticancer agent (cisplatin/gemcitabine), used concomitantly with hemodialysis, which delivers an extremely high concentration of anticancer agent to the site of a tumor without systemic adverse effects, along with concurrent radiation (referred to as the OMC-regimen) in patients with advanced bladder cancer. One hundred and ninety-two patients were assigned to receive either the OMCregimen (n=96) or total cystectomy (n=96). Patients in the OMC-regimen group who failed to achieve CR underwent cystectomy, or secondary BOAI with an increased amount of CDDP or gemcitabine (1600 mg). The OMC-regimen allowed >89% (69/77) of patients with locally invasive tumors to achieve CR [>70% (70/96) of all patients including those with T4 and N(+) disease]. Most (68/69) of the CR patients were still alive with no evidence of recurrence after a mean follow-up of 161 (range 12-805) weeks. The 5-and 15-year overall survival rates were 91.5 and 81.3% (vs. 59.8% and 40.1% for cystectomy, P<0.0001), respectively. No patients suffered Grade III or more severe toxicities. In contrast, at 5 and 15 years after surgery in the total cystectomy group, about 50 and 60% of patients had suffered disease progression or had died, respectively. The OMC-regimen, a new bladderpreservation strategy for patients with locally invasive bladder cancer, can be curative not only in patients for whom cystectomy is indicated, but also in patients whose condition is not amenable to curative treatment and for whom merely palliative therapy would otherwise seem the only option.

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RTOG 97-06: Initial report of a Phase I–II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with cisplatin, and adjuvant MCV combination chemotherapy

Cited by 190 publications

References 23 publications

Bladder-Preservation Therapy in Muscle-Invasive Bladder Cancer: A Single Centre Experience

Bladder-Preservation Therapy in Muscle-Invasive Bladder Cancer: A Single Centre Experience

Bladder Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Novel bladder preservation therapy for locally invasive bladder cancer: Combined therapy using balloon-occluded arterial infusion of anticancer agent and hemodialysis with concurrent radiation

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