Continuous intra-arterial administration of recombinant interleukin-2 in low-stage bladder cancer: A phase IB study

A. Tubaro; F. Velotti; A. Stoppacciaro; A. Santoni; C. Vicentini; P. C. Bossola; P. Galassi; A. Pettinato; S. Morrone; T. Napolitano; L. Frati; L. Ruco; C. R. Franks; P. A. Palmer; C. N. Pourreau; L. Miano

Continuous intra-arterial administration of recombinant interleukin-2 in low-stage bladder cancer: A phase IB study

A. Tubaro, F. Velotti, A. Stoppacciaro, A. Santoni, C. Vicentini, P. C. Bossola, P. Galassi, A. Pettinato, S. Morrone, T. Napolitano, L. Frati, L. Ruco, C. R. Franks, P. A. Palmer, C. N. Pourreau, L. Miano

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Research output: Contribution to journal › Article › peer-review

Abstract

Toxicity and clinical effects of intra-arterial (IA) continuous infusion of recombinant interleukin-2 (rIL-2) were evaluated in twelve patients with low-stage transitional cell carcinoma (TCC) of the bladder (T1NOMO; G1 to G2). rIL-2 dosages were escalated from 18 x 10³ to 18 x 10⁶ IU/m²/d in four groups of three patients. After two 5-day courses, separated by a 48- hour interval, evaluation of clinical response and transurethral resection (TUR) were carried out. World Health Organization (WHO) Grade 3 toxicity occurred in 2 of 12 patients (hypotension/mental confusion and fever, respectively); all side effects rapidly disappeared after infusion was abandoned. No laboratory toxicity developed in any patient. Two pathologically proven complete responses (CR) were achieved using 18 x 10⁴ IU/m²/d, and three partial responses (PR) were achieved using 18 x 10⁵ IU/m²/d in two patients and 18 x 10⁶ IU/m²/d in one patient, giving an overall response rate of 42%. All objective responses are still ongoing after a mean follow-up time of 23 months (range, 12 to 32 months). Local relapses occurred 3 months after TUR only in two nonresponders.

Original language	English
Pages (from-to)	56-61
Number of pages	6
Journal	Cancer
Volume	68
Issue number	1
Publication status	Published - 1991

ASJC Scopus subject areas

Cancer Research
Oncology

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Tubaro, A., Velotti, F., Stoppacciaro, A., Santoni, A., Vicentini, C., Bossola, P. C., Galassi, P., Pettinato, A., Morrone, S., Napolitano, T., Frati, L., Ruco, L., Franks, C. R., Palmer, P. A., Pourreau, C. N., & Miano, L. (1991). Continuous intra-arterial administration of recombinant interleukin-2 in low-stage bladder cancer: A phase IB study. Cancer, 68(1), 56-61.

Continuous intra-arterial administration of recombinant interleukin-2 in low-stage bladder cancer : A phase IB study. / Tubaro, A.; Velotti, F.; Stoppacciaro, A.; Santoni, A.; Vicentini, C.; Bossola, P. C.; Galassi, P.; Pettinato, A.; Morrone, S.; Napolitano, T.; Frati, L.; Ruco, L.; Franks, C. R.; Palmer, P. A.; Pourreau, C. N.; Miano, L.

In: Cancer, Vol. 68, No. 1, 1991, p. 56-61.

Research output: Contribution to journal › Article › peer-review

Tubaro, A. ; Velotti, F. ; Stoppacciaro, A. ; Santoni, A. ; Vicentini, C. ; Bossola, P. C. ; Galassi, P. ; Pettinato, A. ; Morrone, S. ; Napolitano, T. ; Frati, L. ; Ruco, L. ; Franks, C. R. ; Palmer, P. A. ; Pourreau, C. N. ; Miano, L. / Continuous intra-arterial administration of recombinant interleukin-2 in low-stage bladder cancer : A phase IB study. In: Cancer. 1991 ; Vol. 68, No. 1. pp. 56-61.

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abstract = "Toxicity and clinical effects of intra-arterial (IA) continuous infusion of recombinant interleukin-2 (rIL-2) were evaluated in twelve patients with low-stage transitional cell carcinoma (TCC) of the bladder (T1NOMO; G1 to G2). rIL-2 dosages were escalated from 18 x 103 to 18 x 106 IU/m2/d in four groups of three patients. After two 5-day courses, separated by a 48- hour interval, evaluation of clinical response and transurethral resection (TUR) were carried out. World Health Organization (WHO) Grade 3 toxicity occurred in 2 of 12 patients (hypotension/mental confusion and fever, respectively); all side effects rapidly disappeared after infusion was abandoned. No laboratory toxicity developed in any patient. Two pathologically proven complete responses (CR) were achieved using 18 x 104 IU/m2/d, and three partial responses (PR) were achieved using 18 x 105 IU/m2/d in two patients and 18 x 106 IU/m2/d in one patient, giving an overall response rate of 42%. All objective responses are still ongoing after a mean follow-up time of 23 months (range, 12 to 32 months). Local relapses occurred 3 months after TUR only in two nonresponders.",

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AB - Toxicity and clinical effects of intra-arterial (IA) continuous infusion of recombinant interleukin-2 (rIL-2) were evaluated in twelve patients with low-stage transitional cell carcinoma (TCC) of the bladder (T1NOMO; G1 to G2). rIL-2 dosages were escalated from 18 x 103 to 18 x 106 IU/m2/d in four groups of three patients. After two 5-day courses, separated by a 48- hour interval, evaluation of clinical response and transurethral resection (TUR) were carried out. World Health Organization (WHO) Grade 3 toxicity occurred in 2 of 12 patients (hypotension/mental confusion and fever, respectively); all side effects rapidly disappeared after infusion was abandoned. No laboratory toxicity developed in any patient. Two pathologically proven complete responses (CR) were achieved using 18 x 104 IU/m2/d, and three partial responses (PR) were achieved using 18 x 105 IU/m2/d in two patients and 18 x 106 IU/m2/d in one patient, giving an overall response rate of 42%. All objective responses are still ongoing after a mean follow-up time of 23 months (range, 12 to 32 months). Local relapses occurred 3 months after TUR only in two nonresponders.

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