Multicenter study of superficial bladder cancer treated with intravesical bacillus Calmette-Guérin or adriamycin

Khanna, Om P.; Heel, Michael; Son, Daniel L.; Rezvan, Masoud; Mazer, Howard; Viek, Nicholas F.; Read, John; Uhlman, Richard C.; Nugent, Dennis; Friedmann, Marvin; Cottone, R. Rocco

doi:10.1016/0090-4295(90)80052-o

Cited by 33 publications

(13 citation statements)

References 16 publications

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“…In the present series, the observed net benefit of EPI treatment and relatively high response rate to this treat ment protocol were rather favorable to the initial average response demonstrated in previous clinical trials with doxorubicin (with rates ranging from 27 to 77% |9, [12][13][14][15][16][17]. However, the data of those trials are not comparable with those in this study, as different treatment protocols, response definition, entrance criteria and duration of fol low-up were used in patients at different levels of risk for tumor recurrence.…”

Section: Discussionmentioning

confidence: 53%

“…EPI was well tolerated with a rather lower rate of side effects than that observed with doxorubicin [3,12,[15][16][17], but the data again are not comparable. In sum mary, intravesical EPI, given according to the present modified treatment schedule, in addition to its acceptable toxicity, appeared to be notably effective in delaying or preventing recurrence in virtually all tumor types.…”

Section: Discussionmentioning

confidence: 61%

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Prophylaxis of Superficial Bladder Cancer with a Modified Intravesical Epirubicin Treatment Schedule

Melekos¹

1993

Oncology

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A controlled prospective trial on 99 eligible patients evaluated the efficacy of intravesical epirubicin administration as prophylaxis against tumor recurrences after complete endoscopic resection of superficial bladder cancer. The treatment schedule consisting of an initial 6- or 8-week course of instillations, followed by single maintenance doses (to the responders) at follow-up examinations, was modified in those of the initial responders who were at high risk for recurrence and who received an additional separate 4-week course of therapy. Sixty percent of the epirubicin-treated patients and 41 % of the controls (who underwent resection alone) remained free of recurrences for a mean follow-up of 32.1 months, but the difference was not significant. However, in terms of relative risk for recurrences (recurrence rate per 100 patient-months and disease-free interval), comparisons between the two groups of patients revealed a significant benefit of epirubicin, overall as well as for those with a history of previous tumor recurrences, multifocal disease, and stage Ta and grade 2 neoplasms. Drug-induced toxicity was acceptable.

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Section: Discussionmentioning

confidence: 53%

Section: Discussionmentioning

confidence: 61%

Prophylaxis of Superficial Bladder Cancer with a Modified Intravesical Epirubicin Treatment Schedule

Melekos¹

1993

Oncology

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“…Generally either increase in dose, or more fre quent instillations may be required. Furthermore, judge ment of the effectiveness of any instilled drug may neces sitate repeated application over a period of time [1][2][3][4][5]. In order to overcome these shortcomings, we developed a pharmaceutical preparation with the characteristic of ad hesion to the mucous membrane, and obtained the adhe sive anticancer drug hydroxypropylcellulose-doxorubicin (HPC-doxorubicin) for practical application [6], Its posi tive features are that retention time within the urinary bladder is longer than for a water-soluble doxorubicin solution (doxorubicin hydrochloride), and that the drug in this form absorbed more efficiently by cancer tissues than by the normal urinary bladder mucous membrane [7].…”

Section: Introductionmentioning

confidence: 99%

“…Tumor tissue resected by TUR was examined pathohistologically to ascertain whether viable cells were present. effects after TUR can be achieved [1][2][3][4][5]. For either pur pose, the conventional preparation form of the drug in stilled is water-soluble.…”

Section: Introductionmentioning

confidence: 99%

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One-Shot Intravesical Instillation of the Mucous Adhesive Anticancer Agent Hydroxypropylcellulose- Doxorubicin for the Treatment of Superficial Bladder Carcinoma Is Sufficient to Determine Antitumor Effects

Ueda¹,

Sakagami²,

Masui³

et al. 1993

Eur Urol

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Bacillus calmette—Guérin treatment of existing papillary bladder cancer and carcinoma in situ of the bladder. Four-year results

Akaza

Hinotsu

Aso

et al. 1995

Cancer

107

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Background. Intravesical instillation therapy of Bacillus Calmette‐Guérin (BCG) has become a standard treatment for carcinoma in situ (CIS) of the urinary bladder. However, there have been few reports concerning the direct effect of BCG on existing tumors classified as Ta or T1. In the first stage of this clinical study, 157 patients were treated with BCG intravesical instillation (Tokyo 172 strain [BCG Co. Ltd., Tokyo, Japan]; 80 mg weekly for eight times) by our Study Group. The efficacy on existing tumors was a complete response (CR) rate of 84.4% and 66.4% and a partial response (PR) of 6.3% and 20.8% for 32 cases of CIS and 125 cases of Ta or T1 tumors, respectively. Methods. In the second stage of this study, the authors investigated the outcome of the 138 patients who had achieved CR or PR in the first stage. One hundred twenty (87.0%) of the patients were followed fully. Of those patients, 52 were randomized to receive prophylactic (maintenance) therapy consisting of BCG of 40 mg monthly for 12 times (Group A), whereas 55 were randomized to an untreated control group (Group B). Thirteen other patients refused to be randomized and were followed without prophylactic instillation. Results. The median follow‐up period was 48 months for Group A and 42 months for Group B. In Groups A and B, the beneficial effect of the BCG therapeutic instillation persisted for a long time, and the 3‐year nonrecurrence rate was 77.6% in Group A and 74.2% in Group B. Disease progression was observed rarely. Conclusion. For patients in whom transurethral resection of tumors of the bladder (TUR‐Bt) alone is unlikely to eliminate the tumor, intravesical BCG is potentially the treatment of choice. Cancer 1995;75:552‐9.

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Multicenter study of superficial bladder cancer treated with intravesical bacillus Calmette-Guérin or adriamycin

Cited by 33 publications

References 16 publications

Prophylaxis of Superficial Bladder Cancer with a Modified Intravesical Epirubicin Treatment Schedule

Prophylaxis of Superficial Bladder Cancer with a Modified Intravesical Epirubicin Treatment Schedule

One-Shot Intravesical Instillation of the Mucous Adhesive Anticancer Agent Hydroxypropylcellulose- Doxorubicin for the Treatment of Superficial Bladder Carcinoma Is Sufficient to Determine Antitumor Effects

Bacillus calmette—Guérin treatment of existing papillary bladder cancer and carcinoma in situ of the bladder. Four-year results

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