OpenAccessBelV2, PascalFrancis, Corpus, bibRecord, 000092

An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer

Identifieur interne : 000092 ( PascalFrancis/Corpus ); précédent : 000091; suivant : 000093

An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer

Auteurs : M. Venturini ; R. Paridaens ; D. Rossner ; M. M. Vaslamatzis ; J. W. R. Nortier ; M. Salzberg ; H. Rodrigues ; R. Bell

Source :

Oncology [ 0030-2414 ] ; 2007.

RBID : Pascal:08-0002287

Descripteurs français

Pascal (Inist)
- Capécitabine, Etude multicentrique, Ambulatoire, Métastase, Homme, Stade avancé, Accessibilité, Programme, Traitement, Cancérologie, Anticancéreux, Monothérapie, Cancer du sein.

English descriptors

KwdEn :
- Accessibility, Advanced stage, Ambulatory, Antineoplastic agent, Breast cancer, Cancerology, Capecitabine, Human, Metastasis, Monotherapy, Multicenter study, Program, Treatment.

Abstract

Background: Phase Il/III trials have shown that capecitabine is an active, well-tolerated therapy for metastatic breast cancer (MBC). We report clinical findings from an expanded access program enabling patients ineligible for investigative trials to receive capecitabine before its approval and availability. Methods: Patients pretreated with at least two chemotherapy regimens, including a taxane, for MBC received oral capecitabine until disease progression or unacceptable toxicity. Results: Six hundred and thirty-one patients received capecitabine (mean duration 3.8 months, range 0.1-24.7 months). The most common treatment-related grade 3/4 toxicities were diarrhea (9%) and hand-foot syndrome (8%). Grade 3/4 alopecia was absent and grade 3/4 myelosuppression was rare. Dose was modified in 172 patients (27%). Objective response rate in 349 evaluable patients was 35%. Median time to progression (n = 604) was 6.6 months (95% confidence interval, Cl, 5.6-7.6) and median overall survival (n = 569) was 10.0 months (95% Cl, 8.5-15.3). Conclusions: Our findings in a cohort of patients with pretreated progressive breast cancer confirm the high efficacy and tolerability of outpatient capecitabine.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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Format Inist (serveur)

NO :	PASCAL 08-0002287 INIST
ET :	An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer
AU :	VENTURINI (M.); PARIDAENS (R.); ROSSNER (D.); VASLAMATZIS (M. M.); NORTIER (J. W. R.); SALZBERG (M.); RODRIGUES (H.); BELL (R.)
AF :	Medical Oncology Department/Negrar/Italie (1 aut.); University Hospital Gasthuisberg, Katholieke Universiteit Leuven/Leuven/Belgique (2 aut.); Medical University of Hannover/Hannover/Allemagne (3 aut.); Department of Medical Oncology, Evangelismos Hospital/Athens/Grèce (4 aut.); Leiden University Medical Center/Leiden/Pays-Bas (5 aut.); University Hospital/Basel/Suisse (6 aut.); Institute Portugues de Oncologia/Porto/Portugal (7 aut.); Andrew Love Cancer Center, Geelong Hospital/Geelong/Australie (8 aut.)
DT :	Publication en série; Niveau analytique
SO :	Oncology; ISSN 0030-2414; Suisse; Da. 2007; Vol. 72; No. 1-2; Pp. 51-57; Bibl. 17 ref.
LA :	Anglais
EA :	Background: Phase Il/III trials have shown that capecitabine is an active, well-tolerated therapy for metastatic breast cancer (MBC). We report clinical findings from an expanded access program enabling patients ineligible for investigative trials to receive capecitabine before its approval and availability. Methods: Patients pretreated with at least two chemotherapy regimens, including a taxane, for MBC received oral capecitabine until disease progression or unacceptable toxicity. Results: Six hundred and thirty-one patients received capecitabine (mean duration 3.8 months, range 0.1-24.7 months). The most common treatment-related grade 3/4 toxicities were diarrhea (9%) and hand-foot syndrome (8%). Grade 3/4 alopecia was absent and grade 3/4 myelosuppression was rare. Dose was modified in 172 patients (27%). Objective response rate in 349 evaluable patients was 35%. Median time to progression (n = 604) was 6.6 months (95% confidence interval, Cl, 5.6-7.6) and median overall survival (n = 569) was 10.0 months (95% Cl, 8.5-15.3). Conclusions: Our findings in a cohort of patients with pretreated progressive breast cancer confirm the high efficacy and tolerability of outpatient capecitabine.
CC :	002B04; 002B20E02
FD :	Capécitabine; Etude multicentrique; Ambulatoire; Métastase; Homme; Stade avancé; Accessibilité; Programme; Traitement; Cancérologie; Anticancéreux; Monothérapie; Cancer du sein
FG :	Dérivé de la fluoropyrimidine; Pyrimidine nucléoside; Tumeur maligne; Cancer; Pathologie de la glande mammaire
ED :	Capecitabine; Multicenter study; Ambulatory; Metastasis; Human; Advanced stage; Accessibility; Program; Treatment; Cancerology; Antineoplastic agent; Monotherapy; Breast cancer
EG :	Fluoropyrimidine derivatives; Pyrimidine nucleoside; Malignant tumor; Cancer; Mammary gland diseases
SD :	Capecitabina; Estudio multicéntrico; Ambulatorio; Metástasis; Hombre; Estadio avanzado; Accesibilidad; Programa; Tratamiento; Cancerología; Anticanceroso; Cáncer de pecho
LO :	INIST-5519.354000161726040090
ID :	08-0002287

Links to Exploration step

Pascal:08-0002287

Le document en format XML

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<front><div type="abstract" xml:lang="en">Background: Phase Il/III trials have shown that capecitabine is an active, well-tolerated therapy for metastatic breast cancer (MBC). We report clinical findings from an expanded access program enabling patients ineligible for investigative trials to receive capecitabine before its approval and availability. Methods: Patients pretreated with at least two chemotherapy regimens, including a taxane, for MBC received oral capecitabine until disease progression or unacceptable toxicity. Results: Six hundred and thirty-one patients received capecitabine (mean duration 3.8 months, range 0.1-24.7 months). The most common treatment-related grade 3/4 toxicities were diarrhea (9%) and hand-foot syndrome (8%). Grade 3/4 alopecia was absent and grade 3/4 myelosuppression was rare. Dose was modified in 172 patients (27%). Objective response rate in 349 evaluable patients was 35%. Median time to progression (n = 604) was 6.6 months (95% confidence interval, Cl, 5.6-7.6) and median overall survival (n = 569) was 10.0 months (95% Cl, 8.5-15.3). Conclusions: Our findings in a cohort of patients with pretreated progressive breast cancer confirm the high efficacy and tolerability of outpatient capecitabine.</div>
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<fA14 i1="02"><s1>University Hospital Gasthuisberg, Katholieke Universiteit Leuven</s1>
<s2>Leuven</s2>
<s3>BEL</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Medical University of Hannover</s1>
<s2>Hannover</s2>
<s3>DEU</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Department of Medical Oncology, Evangelismos Hospital</s1>
<s2>Athens</s2>
<s3>GRC</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Leiden University Medical Center</s1>
<s2>Leiden</s2>
<s3>NLD</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>University Hospital</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Institute Portugues de Oncologia</s1>
<s2>Porto</s2>
<s3>PRT</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Andrew Love Cancer Center, Geelong Hospital</s1>
<s2>Geelong</s2>
<s3>AUS</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA20><s1>51-57</s1>
</fA20>
<fA21><s1>2007</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
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<s1>© 2008 INIST-CNRS. All rights reserved.</s1>
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</fA45>
<fA47 i1="01" i2="1"><s0>08-0002287</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
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</fA64>
<fA66 i1="01"><s0>CHE</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Background: Phase Il/III trials have shown that capecitabine is an active, well-tolerated therapy for metastatic breast cancer (MBC). We report clinical findings from an expanded access program enabling patients ineligible for investigative trials to receive capecitabine before its approval and availability. Methods: Patients pretreated with at least two chemotherapy regimens, including a taxane, for MBC received oral capecitabine until disease progression or unacceptable toxicity. Results: Six hundred and thirty-one patients received capecitabine (mean duration 3.8 months, range 0.1-24.7 months). The most common treatment-related grade 3/4 toxicities were diarrhea (9%) and hand-foot syndrome (8%). Grade 3/4 alopecia was absent and grade 3/4 myelosuppression was rare. Dose was modified in 172 patients (27%). Objective response rate in 349 evaluable patients was 35%. Median time to progression (n = 604) was 6.6 months (95% confidence interval, Cl, 5.6-7.6) and median overall survival (n = 569) was 10.0 months (95% Cl, 8.5-15.3). Conclusions: Our findings in a cohort of patients with pretreated progressive breast cancer confirm the high efficacy and tolerability of outpatient capecitabine.</s0>
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<fC02 i1="01" i2="X"><s0>002B04</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B20E02</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Capécitabine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Capecitabine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
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<s2>FR</s2>
<s5>01</s5>
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<s5>03</s5>
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<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Métastase</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Metastasis</s0>
<s5>04</s5>
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<fC03 i1="04" i2="X" l="SPA"><s0>Metástasis</s0>
<s5>04</s5>
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<fC03 i1="05" i2="X" l="FRE"><s0>Homme</s0>
<s5>05</s5>
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<s5>05</s5>
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<s5>05</s5>
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<s5>06</s5>
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<s5>06</s5>
</fC03>
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<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Accessibilité</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Accessibility</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Accesibilidad</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Programme</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Program</s0>
<s5>09</s5>
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<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Traitement</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Treatment</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>11</s5>
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<fC03 i1="10" i2="X" l="FRE"><s0>Cancérologie</s0>
<s5>12</s5>
</fC03>
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<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Cancerología</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Anticancéreux</s0>
<s5>25</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Antineoplastic agent</s0>
<s5>25</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>25</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Monothérapie</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Monotherapy</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Cancer du sein</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Breast cancer</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Cáncer de pecho</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Dérivé de la fluoropyrimidine</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Fluoropyrimidine derivatives</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Fluoropirimidina derivado</s0>
<s5>37</s5>
</fC07>
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<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Pyrimidine nucleoside</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Pirimidina nucleósido</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Tumeur maligne</s0>
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<s5>39</s5>
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<s5>39</s5>
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<s2>NM</s2>
<s5>39</s5>
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<fC07 i1="04" i2="X" l="FRE"><s0>Cancer</s0>
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<s2>NM</s2>
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<fC07 i1="04" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
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<fC07 i1="05" i2="X" l="FRE"><s0>Pathologie de la glande mammaire</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Mammary gland diseases</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Glándula mamaria patología</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fN21><s1>007</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
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<fN82><s1>OTO</s1>
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<server><NO>PASCAL 08-0002287 INIST</NO>
<ET>An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer</ET>
<AU>VENTURINI (M.); PARIDAENS (R.); ROSSNER (D.); VASLAMATZIS (M. M.); NORTIER (J. W. R.); SALZBERG (M.); RODRIGUES (H.); BELL (R.)</AU>
<AF>Medical Oncology Department/Negrar/Italie (1 aut.); University Hospital Gasthuisberg, Katholieke Universiteit Leuven/Leuven/Belgique (2 aut.); Medical University of Hannover/Hannover/Allemagne (3 aut.); Department of Medical Oncology, Evangelismos Hospital/Athens/Grèce (4 aut.); Leiden University Medical Center/Leiden/Pays-Bas (5 aut.); University Hospital/Basel/Suisse (6 aut.); Institute Portugues de Oncologia/Porto/Portugal (7 aut.); Andrew Love Cancer Center, Geelong Hospital/Geelong/Australie (8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Oncology; ISSN 0030-2414; Suisse; Da. 2007; Vol. 72; No. 1-2; Pp. 51-57; Bibl. 17 ref.</SO>
<LA>Anglais</LA>
<EA>Background: Phase Il/III trials have shown that capecitabine is an active, well-tolerated therapy for metastatic breast cancer (MBC). We report clinical findings from an expanded access program enabling patients ineligible for investigative trials to receive capecitabine before its approval and availability. Methods: Patients pretreated with at least two chemotherapy regimens, including a taxane, for MBC received oral capecitabine until disease progression or unacceptable toxicity. Results: Six hundred and thirty-one patients received capecitabine (mean duration 3.8 months, range 0.1-24.7 months). The most common treatment-related grade 3/4 toxicities were diarrhea (9%) and hand-foot syndrome (8%). Grade 3/4 alopecia was absent and grade 3/4 myelosuppression was rare. Dose was modified in 172 patients (27%). Objective response rate in 349 evaluable patients was 35%. Median time to progression (n = 604) was 6.6 months (95% confidence interval, Cl, 5.6-7.6) and median overall survival (n = 569) was 10.0 months (95% Cl, 8.5-15.3). Conclusions: Our findings in a cohort of patients with pretreated progressive breast cancer confirm the high efficacy and tolerability of outpatient capecitabine.</EA>
<CC>002B04; 002B20E02</CC>
<FD>Capécitabine; Etude multicentrique; Ambulatoire; Métastase; Homme; Stade avancé; Accessibilité; Programme; Traitement; Cancérologie; Anticancéreux; Monothérapie; Cancer du sein</FD>
<FG>Dérivé de la fluoropyrimidine; Pyrimidine nucléoside; Tumeur maligne; Cancer; Pathologie de la glande mammaire</FG>
<ED>Capecitabine; Multicenter study; Ambulatory; Metastasis; Human; Advanced stage; Accessibility; Program; Treatment; Cancerology; Antineoplastic agent; Monotherapy; Breast cancer</ED>
<EG>Fluoropyrimidine derivatives; Pyrimidine nucleoside; Malignant tumor; Cancer; Mammary gland diseases</EG>
<SD>Capecitabina; Estudio multicéntrico; Ambulatorio; Metástasis; Hombre; Estadio avanzado; Accesibilidad; Programa; Tratamiento; Cancerología; Anticanceroso; Cáncer de pecho</SD>
<LO>INIST-5519.354000161726040090</LO>
<ID>08-0002287</ID>
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An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer

An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer

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