Bicalutamide (B) monotherapy versus flutamide (F) plus goserelin (G) in prostate cancer (CA) patients (PTS). Preliminary results of an italian prostate cancer group (PONCAP) study

Umberto Ponti, Mario Barichello, Francesco P. Selvaggi, Michele Battagia, Gian Carlo Comeri, Giario Conti, Vincenzo Santo, Franco Montefiore, Valentine Ferraris, Sergio Lilliu, Sandro Dammino, Giovanni Spano, Alessandra Rubagotti, Francesco Boccardo

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Abstract

INTRODUCTION AND OBJECTIVES: The role of monotherapy with pure antiandrogens in pts with advanced prostate ca is still controversial. The purposes of the present study were: I) To evaluate the efficacy of B monotherapy as compared to total androgen deprivation; 2} to compare the toxicity of B versus that of F. METHODS: From March, 1993 until September, 1996, 220 pts with hystologically proven, locally advanced or metastatic prostate ca were randomly allocated to receive either B monotherapy, 150 mg daily (no=108) or F, 750 mg daily, plus G dpt, 3.6 mg every 4 weeks (no=l 12) until disease progression or toxicity. Pts characteristics: group B: median age, 74 (48-82); median PS (ECOG), 0 (0-2); stage C (AUS), 45%; stage D, 55%; G1-G2, 64%; median initial PSA level, 52 ng/ml (0.6-780); group F+G: median age, 74 (55-88); median PS, 0 (0-2); stage C, 38%; stage D, 62%; G1-G2, 54%; median initial PSA level, 75.5 ng/ml (1-6641). RESULTS: At a median f.u. time of 20 mos (1-40) overall 88 pts progressed (B: 42; F+G: 46) and 50 pts died (B: 21; F+G: 29). Median PFS in mos: all pts: B, 24; F+G, 23: n.s.; stage D: B, 19; F+G, 19: n.s.. Median S: all pts: B, not reached; F+G, 34 mos: n.s.. PSA normalized in 79% of pts in group B and in 86% in group F+G: n.s.. Diarrhea and hot flushes were more common in group F+G (p=0.000 both ones), while gynecomastia was more common in group B (p=0.001). Treatment was discontinued in 2% of pts receiving B and in 16.5% of pts receiving F (p=0.000). 20/52 pts maintained normal erections in group B as compared to 5/60 in group F+G (p=0.000). CONCLUSIONS: 1) B monotherapy was safe and as effective as total androgen deprivation, independently of disease stage; 2) B was better tolerated than F and used as monotherapy allowed a better quality of life.

Original languageEnglish
Pages (from-to)276
Number of pages1
JournalBritish Journal of Urology
Volume80
Issue numberSUPPL. 2
Publication statusPublished - 1997

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Goserelin
Flutamide
Androgens
Prostate
Prostatic Neoplasms
Gynecomastia
Androgen Antagonists
Disease Progression
Diarrhea
Quality of Life
bicalutamide

ASJC Scopus subject areas

  • Urology

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Bicalutamide (B) monotherapy versus flutamide (F) plus goserelin (G) in prostate cancer (CA) patients (PTS). Preliminary results of an italian prostate cancer group (PONCAP) study. / Ponti, Umberto; Barichello, Mario; Selvaggi, Francesco P.; Battagia, Michele; Comeri, Gian Carlo; Conti, Giario; Santo, Vincenzo; Montefiore, Franco; Ferraris, Valentine; Lilliu, Sergio; Dammino, Sandro; Spano, Giovanni; Rubagotti, Alessandra; Boccardo, Francesco.

In: British Journal of Urology, Vol. 80, No. SUPPL. 2, 1997, p. 276.

Research output: Contribution to journalArticle

Ponti, U, Barichello, M, Selvaggi, FP, Battagia, M, Comeri, GC, Conti, G, Santo, V, Montefiore, F, Ferraris, V, Lilliu, S, Dammino, S, Spano, G, Rubagotti, A & Boccardo, F 1997, 'Bicalutamide (B) monotherapy versus flutamide (F) plus goserelin (G) in prostate cancer (CA) patients (PTS). Preliminary results of an italian prostate cancer group (PONCAP) study', British Journal of Urology, vol. 80, no. SUPPL. 2, pp. 276.
Ponti, Umberto ; Barichello, Mario ; Selvaggi, Francesco P. ; Battagia, Michele ; Comeri, Gian Carlo ; Conti, Giario ; Santo, Vincenzo ; Montefiore, Franco ; Ferraris, Valentine ; Lilliu, Sergio ; Dammino, Sandro ; Spano, Giovanni ; Rubagotti, Alessandra ; Boccardo, Francesco. / Bicalutamide (B) monotherapy versus flutamide (F) plus goserelin (G) in prostate cancer (CA) patients (PTS). Preliminary results of an italian prostate cancer group (PONCAP) study. In: British Journal of Urology. 1997 ; Vol. 80, No. SUPPL. 2. pp. 276.
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title = "Bicalutamide (B) monotherapy versus flutamide (F) plus goserelin (G) in prostate cancer (CA) patients (PTS). Preliminary results of an italian prostate cancer group (PONCAP) study",
abstract = "INTRODUCTION AND OBJECTIVES: The role of monotherapy with pure antiandrogens in pts with advanced prostate ca is still controversial. The purposes of the present study were: I) To evaluate the efficacy of B monotherapy as compared to total androgen deprivation; 2} to compare the toxicity of B versus that of F. METHODS: From March, 1993 until September, 1996, 220 pts with hystologically proven, locally advanced or metastatic prostate ca were randomly allocated to receive either B monotherapy, 150 mg daily (no=108) or F, 750 mg daily, plus G dpt, 3.6 mg every 4 weeks (no=l 12) until disease progression or toxicity. Pts characteristics: group B: median age, 74 (48-82); median PS (ECOG), 0 (0-2); stage C (AUS), 45{\%}; stage D, 55{\%}; G1-G2, 64{\%}; median initial PSA level, 52 ng/ml (0.6-780); group F+G: median age, 74 (55-88); median PS, 0 (0-2); stage C, 38{\%}; stage D, 62{\%}; G1-G2, 54{\%}; median initial PSA level, 75.5 ng/ml (1-6641). RESULTS: At a median f.u. time of 20 mos (1-40) overall 88 pts progressed (B: 42; F+G: 46) and 50 pts died (B: 21; F+G: 29). Median PFS in mos: all pts: B, 24; F+G, 23: n.s.; stage D: B, 19; F+G, 19: n.s.. Median S: all pts: B, not reached; F+G, 34 mos: n.s.. PSA normalized in 79{\%} of pts in group B and in 86{\%} in group F+G: n.s.. Diarrhea and hot flushes were more common in group F+G (p=0.000 both ones), while gynecomastia was more common in group B (p=0.001). Treatment was discontinued in 2{\%} of pts receiving B and in 16.5{\%} of pts receiving F (p=0.000). 20/52 pts maintained normal erections in group B as compared to 5/60 in group F+G (p=0.000). CONCLUSIONS: 1) B monotherapy was safe and as effective as total androgen deprivation, independently of disease stage; 2) B was better tolerated than F and used as monotherapy allowed a better quality of life.",
author = "Umberto Ponti and Mario Barichello and Selvaggi, {Francesco P.} and Michele Battagia and Comeri, {Gian Carlo} and Giario Conti and Vincenzo Santo and Franco Montefiore and Valentine Ferraris and Sergio Lilliu and Sandro Dammino and Giovanni Spano and Alessandra Rubagotti and Francesco Boccardo",
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T1 - Bicalutamide (B) monotherapy versus flutamide (F) plus goserelin (G) in prostate cancer (CA) patients (PTS). Preliminary results of an italian prostate cancer group (PONCAP) study

AU - Ponti, Umberto

AU - Barichello, Mario

AU - Selvaggi, Francesco P.

AU - Battagia, Michele

AU - Comeri, Gian Carlo

AU - Conti, Giario

AU - Santo, Vincenzo

AU - Montefiore, Franco

AU - Ferraris, Valentine

AU - Lilliu, Sergio

AU - Dammino, Sandro

AU - Spano, Giovanni

AU - Rubagotti, Alessandra

AU - Boccardo, Francesco

PY - 1997

Y1 - 1997

N2 - INTRODUCTION AND OBJECTIVES: The role of monotherapy with pure antiandrogens in pts with advanced prostate ca is still controversial. The purposes of the present study were: I) To evaluate the efficacy of B monotherapy as compared to total androgen deprivation; 2} to compare the toxicity of B versus that of F. METHODS: From March, 1993 until September, 1996, 220 pts with hystologically proven, locally advanced or metastatic prostate ca were randomly allocated to receive either B monotherapy, 150 mg daily (no=108) or F, 750 mg daily, plus G dpt, 3.6 mg every 4 weeks (no=l 12) until disease progression or toxicity. Pts characteristics: group B: median age, 74 (48-82); median PS (ECOG), 0 (0-2); stage C (AUS), 45%; stage D, 55%; G1-G2, 64%; median initial PSA level, 52 ng/ml (0.6-780); group F+G: median age, 74 (55-88); median PS, 0 (0-2); stage C, 38%; stage D, 62%; G1-G2, 54%; median initial PSA level, 75.5 ng/ml (1-6641). RESULTS: At a median f.u. time of 20 mos (1-40) overall 88 pts progressed (B: 42; F+G: 46) and 50 pts died (B: 21; F+G: 29). Median PFS in mos: all pts: B, 24; F+G, 23: n.s.; stage D: B, 19; F+G, 19: n.s.. Median S: all pts: B, not reached; F+G, 34 mos: n.s.. PSA normalized in 79% of pts in group B and in 86% in group F+G: n.s.. Diarrhea and hot flushes were more common in group F+G (p=0.000 both ones), while gynecomastia was more common in group B (p=0.001). Treatment was discontinued in 2% of pts receiving B and in 16.5% of pts receiving F (p=0.000). 20/52 pts maintained normal erections in group B as compared to 5/60 in group F+G (p=0.000). CONCLUSIONS: 1) B monotherapy was safe and as effective as total androgen deprivation, independently of disease stage; 2) B was better tolerated than F and used as monotherapy allowed a better quality of life.

AB - INTRODUCTION AND OBJECTIVES: The role of monotherapy with pure antiandrogens in pts with advanced prostate ca is still controversial. The purposes of the present study were: I) To evaluate the efficacy of B monotherapy as compared to total androgen deprivation; 2} to compare the toxicity of B versus that of F. METHODS: From March, 1993 until September, 1996, 220 pts with hystologically proven, locally advanced or metastatic prostate ca were randomly allocated to receive either B monotherapy, 150 mg daily (no=108) or F, 750 mg daily, plus G dpt, 3.6 mg every 4 weeks (no=l 12) until disease progression or toxicity. Pts characteristics: group B: median age, 74 (48-82); median PS (ECOG), 0 (0-2); stage C (AUS), 45%; stage D, 55%; G1-G2, 64%; median initial PSA level, 52 ng/ml (0.6-780); group F+G: median age, 74 (55-88); median PS, 0 (0-2); stage C, 38%; stage D, 62%; G1-G2, 54%; median initial PSA level, 75.5 ng/ml (1-6641). RESULTS: At a median f.u. time of 20 mos (1-40) overall 88 pts progressed (B: 42; F+G: 46) and 50 pts died (B: 21; F+G: 29). Median PFS in mos: all pts: B, 24; F+G, 23: n.s.; stage D: B, 19; F+G, 19: n.s.. Median S: all pts: B, not reached; F+G, 34 mos: n.s.. PSA normalized in 79% of pts in group B and in 86% in group F+G: n.s.. Diarrhea and hot flushes were more common in group F+G (p=0.000 both ones), while gynecomastia was more common in group B (p=0.001). Treatment was discontinued in 2% of pts receiving B and in 16.5% of pts receiving F (p=0.000). 20/52 pts maintained normal erections in group B as compared to 5/60 in group F+G (p=0.000). CONCLUSIONS: 1) B monotherapy was safe and as effective as total androgen deprivation, independently of disease stage; 2) B was better tolerated than F and used as monotherapy allowed a better quality of life.

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