Oral vinorelbine plus capecitabine (oral vincap) combination in patients with advanced breast cancer (ABC). A phase II study of the GOIM (Gruppo Oncologico dell'Italia Meridionale)

Lorusso, Vito; Spada, Massimiliano; Giampaglia, Marianna; Misino, A.; Calabrese, Renee; Latorre, Agnese; Monticelli, G.; Guida, Michele; Sambiasi, D.; Colucci, Giuseppe

doi:10.1093/annonc/mdl942

Cited by 33 publications

(19 citation statements)

References 19 publications

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“…In one study, the combination of oral UFT/leucovorin plusIVvinorelbinewasevaluatedin23advancedbreastcan-cerpatients.Atotalresponserateof22.2%with1complete responsewasobtained.Theregimenwasusedassecond-line treatment; however, neither data regarding anthracycline andtaxaneresistancenorsurvivaldatawerereportedinthis paper [5].Ourresponserateseemedtobeinferiorcompared tothisstudy,butallourpatientswereanthracycline-andtaxane-refractorywhichisunknownfortheotherstudy [5].Ina secondstudy,37metastaticbreastcancerpatientspreviously treatedwithanthracyclinesandtaxanesreceivedIVvinorelbine 30 mg/m 2 on day 1 and UFT 250 mg/m 2 daily, every 2weeks.Atotalof36%ofpatientsachievedPRand19%had SDwithatotal55%diseasecontrol.Mediantimetoprogressionwas18weeks [27].Whiletotaldiseasecontrolandmedian time to progression were similar to our study, the objective responseratewashigherthanwhatweobtainedinourstudy, whichcanonlybeexplainedbydifferencesbetweenthetwo protocols. In a third study, the combination of oral vinorelbineandcapecitabinewasinvestigatedin38metastaticbreast cancerpatientsrefractorytoanthracyclinesandtaxanes,and a39.4%responseratewasreportedwithafavorabletoxicity profile.Themediantimetoprogressionwas4.5monthsand median OS was 10 months [4]. However, in contrast to our studywhereallpatientshadvisceralmetastasis,dominantsites ofdiseasewerebonein26.3%andsofttissuein23.6%ofthe patients.Thismaybeanothercauseoftheinferiorresultsof ourstudycomparedtothisstudy,otherthanusageofdifferent oralfluoropyrimidinesinthetwostudies [4].Inanotherstudy, 52patientswithlocallyadvancedormetastaticbreastcancer were treated with vinorelbine (25 mg/m 2 IV days 1 and 8) plus oral capecitabine (1,000 mg/m 2 twice daily days 1-14) every21days.Allpatientshadreceivedpriortreatmentwith an anthracycline but only 11 (21%) had also received prior taxane.40%ofpatientsachievedCRorPRand2hadstable disease [28].Inarecentstudy,activityoforalvinorelbineand capecitabine was investigated in 25 elderly metastatic breast cancerpatients.Thetreatmentschedulewas60mg/m 2 oforal vinorelbine on days 1 and 8 and capecitabine 1,000 mg/m 2 twicedailydays1-14every3weeks.Inthisstudy,8patients received the combination as first-line, 5 patients as secondline,and12patients>third-line;nodataisavailableregarding taxaneresistance.Outof23evaluablepatients,6(26%)had objectiveresponse:2CRand4PR [29].Inthelast2studies mentioned [28,29],averylownumberofpatientshadpreviously used taxanes.…”

Section: Discussioncontrasting

confidence: 91%

“…In a third study, the combination of oral vinorelbineandcapecitabinewasinvestigatedin38metastaticbreast cancerpatientsrefractorytoanthracyclinesandtaxanes,and a39.4%responseratewasreportedwithafavorabletoxicity profile.Themediantimetoprogressionwas4.5monthsand median OS was 10 months [4]. However, in contrast to our studywhereallpatientshadvisceralmetastasis,dominantsites ofdiseasewerebonein26.3%andsofttissuein23.6%ofthe patients.Thismaybeanothercauseoftheinferiorresultsof ourstudycomparedtothisstudy,otherthanusageofdifferent oralfluoropyrimidinesinthetwostudies [4].Inanotherstudy, 52patientswithlocallyadvancedormetastaticbreastcancer were treated with vinorelbine (25 mg/m 2 IV days 1 and 8) plus oral capecitabine (1,000 mg/m 2 twice daily days 1-14) every21days.Allpatientshadreceivedpriortreatmentwith an anthracycline but only 11 (21%) had also received prior taxane.40%ofpatientsachievedCRorPRand2hadstable disease [28].Inarecentstudy,activityoforalvinorelbineand capecitabine was investigated in 25 elderly metastatic breast cancerpatients.Thetreatmentschedulewas60mg/m 2 oforal vinorelbine on days 1 and 8 and capecitabine 1,000 mg/m 2 twicedailydays1-14every3weeks.Inthisstudy,8patients received the combination as first-line, 5 patients as secondline,and12patients>third-line;nodataisavailableregarding taxaneresistance.Outof23evaluablepatients,6(26%)had objectiveresponse:2CRand4PR [29].Inthelast2studies mentioned [28,29],averylownumberofpatientshadpreviously used taxanes. This might have caused better results in thesestudiescomparedtoourstudyinwhichallpatientswere taxane-refractory.…”

Section: Discussioncontrasting

confidence: 91%

“…Finally, we are sure that oral vinorelbine on day 8 offers betterconveniencetothepatients,andreducestheneedfor IVinjectionsanddecreasestimespentinhospital.However, thecombinationweusedinourstudyshowedinferioractivitycomparedtotheothercombinationsdiscussedabove [4,5,[27][28][29],althoughtherearemanydifferencesbetweenourand theotherstudies,asdiscussedbefore.Inconclusion,whilethis combinationwaswelltoleratedandseemstobeconvenient, it has only moderate activity in metastatic breast cancer in thesecond-linesetting.Theintrinsicantitumoreffectofthis combinationmaybeinferiortoothertreatmentoptionsfor thisdisease.Whetherthatcanbechangedbydifferentdose schedulesisatbestdoubtful.Thepresentstudyisretrospectiveandincludesonlyalimitednumberofpatients.Different dose schedules or routes of administration of the drugs should be investigated in further studies with higher patient numbers.…”

Section: Discussionmentioning

confidence: 99%

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UFT plus Oral Folinic Acid with Alternating Oral and Intravenous Vinorelbine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes

Coşkun

Kaya²,

Alkış³

et al. 2009

Onkologie

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Background: We retrospectively evaluated the activity and toxicity of uracil/tegafur (UFT) plus oral folinic acid in combination with vinorelbine (alternating intravenous (IV) on day 1 and oral on day 8) in patients with metastatic breast cancer. Patients and Methods: Treatment consisted of IV vinorelbine 25 mg/m² on day 1 and 60 mg/m² orally on day 8, and oral UFT 300 mg/m² plus leucovorin 60 mg/m² on days 1–14 with 21 days interval. All patients were refractory to anthracyclines and taxanes. Results: Partial response (PR) was observed in 3 (9.7%) and stable disease (SD) was observed in 13 (41.9%) patients. Total clinical benefit (PR + SD) of the combination was 51.6%. The median response duration was 3 (range 1–11.8) months. Median overall survival was 9.8 months (95% confidence interval (CI): 7.5–12.1), and median time to progression was 3.4 months (95% CI: 2.3–4.5). The most common toxicities were hematologic, including 4 (12.9%) cases of grade 3 neutropenia and 4 (12.9%) cases of grade 4 neutropenia. Grade 3 diarrhea was reported in 2 (3.2%) patients. 3 (9.7%) patients had hand-foot syndrome. Febrile neutropenia was observed in 1 patient. Conclusions: Although the combination is safe and convenient in clinical practice, it has only moderate activity in metastatic breast cancer patients.

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Section: Discussioncontrasting

confidence: 91%

Section: Discussioncontrasting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

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UFT plus Oral Folinic Acid with Alternating Oral and Intravenous Vinorelbine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes

Coşkun

Kaya²,

Alkış³

et al. 2009

Onkologie

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“…Ongoing studies are investigating oral vinorelbine [37,38] , and an international trial investigating a lower dosage of capecitabine (825 vs. 1,000 mg/m 2 b.i.d.) is underway.…”

Section: Discussionmentioning

confidence: 99%

Prospective Study of Vinorelbine and Capecitabine Combination Therapy in Chinese Patients with Metastatic Breast Cancer Pretreated with Anthracyclines and Taxanes

Fan

Yuan

et al. 2010

Chemotherapy

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Aims: This phase II study prospectively evaluated the feasibility of vinorelbine in combination with capecitabine in Chinese patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. Methods: Vinorelbine (25 mg/m² intravenous infusion on days 1 and 8) and capecitabine (1,000 mg/m² b.i.d., days 1–14) were administered to eligible MBC patients previously treated with anthracyclines and taxanes every 3 weeks for up to 6 cycles, until disease progression or unacceptable toxicity. The primary endpoint was objective response. Results: Seventy-two patients were enrolled. In total, 297 cycles were given (median 4 cycles, range 2–6). The overall response rate was 45.8% (95% CI 34.2–57.4%), including 5 complete (6.9%) and 28 partial responses (38.9%). With median follow-up of 22 months, median time to progression was 7.7 months (95% CI 5.5–10.0) and median survival was 26.1 months (95% CI 19.6–32.6). The response rate was 53.8% in patients resistant to anthracyclines and taxanes combination. The most common hematologic adverse events were leukopenia (81.9%) with grade 3/4 incidence of 41.7%; nausea was the most frequent non-hematologic toxicity (62.5%). Hand-foot syndrome occurred in 12.5% of patients, and diarrhea was rare. Conclusions: Capecitabine 1,000 mg/m² b.i.d. combined with vinorelbine 25 mg/m² is an effective and safe treatment for MBC patients, no matter if anthracycline and taxane pretreated or resistant.

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“…Two phase I studies with an all-oral combination of vinorelbine and capecitabine recommended a dosage of capecitabine 2,000 mg/m 2 and vinorelbine 60 mg/m 2 [17,18]. Based upon those data, several phase II studies were initiated [19][20][21][22][23]. Here, we present the results of a prospective observational trial investigating the activity and safety of an all-oral combination chemotherapy of vinorelbine (Navelbine oral ® , Pierre Fabre Pharma, Freiburg, Germany) and capecitabine (Xeloda ® , Roche Pharma AG, Grenzach-Wyhlen, Germany) in HER2-negative, locally advanced, inoperable or metastatic breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Capecitabine and Vinorelbine as an All-Oral Chemotherapy in HER2-Negative Locally Advanced and Metastatic Breast Cancer

et al. 2010

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Background: The oral formulation of vinorelbine together with capecitabine allows for an all-oral combination chemotherapy which promises to raise quality of life of patients with advanced breast cancer. Patients and Methods: Patients with HER2-negative, locally advanced, inoperable or metastatic breast cancer were included in this prospective observational trial (treatment schedule: capecitabine 500 mg/m² twice daily, days 1–14; vinorelbine 60 mg/m², days 1+8; repeated in 3-week cycles). Results: All 32 patients (median age 50 years) were evaluable for toxicity, and 30 patients for response. Twentyfour patients received therapy as first-line treatment, and 8 patients as beyond first-line treatment. Median time to progression was 8 months, and median overall survival was 32 months. Complete response was observed in 1 patient (3%), partial response in 10 patients (33%), and disease stabilization for more than 6 months (SD > 6) in 10 patients (33%). This results in an overall response rate (ORR) of 37% and a clinical benefit rate (ORR + SD > 6) of 70%. The only grade 3/4 toxicities were neutropenia (19%) and hand-foot syndrome (9%). Conclusions: The all-oral combination of capecitabine/vinorelbine at this schedule appears to be an effective, well-tolerated regimen for treatment of advanced breast cancer, and offers a promising alternative to single-agent capecitabine and vinorelbine as well as intravenous polychemotherapy.

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Oral vinorelbine plus capecitabine (oral vincap) combination in patients with advanced breast cancer (ABC). A phase II study of the GOIM (Gruppo Oncologico dell'Italia Meridionale)

Abstract: The oral vincap should be considered as an alternative to single agent capecitabine or vinorelbine in ABC refractory to antra-taxane combination.

Cited by 33 publications

References 19 publications

UFT plus Oral Folinic Acid with Alternating Oral and Intravenous Vinorelbine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes

UFT plus Oral Folinic Acid with Alternating Oral and Intravenous Vinorelbine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes

Prospective Study of Vinorelbine and Capecitabine Combination Therapy in Chinese Patients with Metastatic Breast Cancer Pretreated with Anthracyclines and Taxanes

Capecitabine and Vinorelbine as an All-Oral Chemotherapy in HER2-Negative Locally Advanced and Metastatic Breast Cancer

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