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Article: LC-MS/MS Method for the Quantification of PARP Inhibitors Olaparib, Rucaparib and Niraparib in Human Plasma and Dried Blood Spot: Development, Validation and Clinical Validation for Therapeutic Drug Monitoring.

Canil, Giovanni / Orleni, Marco / Posocco, Bianca / Gagno, Sara / Bignucolo, Alessia / Montico, Marcella / Roncato, Rossana / Corsetti, Serena / Bartoletti, Michele / Toffoli, Giuseppe

Pharmaceutics

2023 Volume 15, Issue 5

Abstract: Poly (ADP-ribose) polymerase inhibitors (PARPis) are becoming increasingly meaningful in oncology, and their therapeutic drug monitoring (TDM) might be beneficial for patients. Several bioanalytical methods have been reported for PARPis quantification in ...

Abstract	Poly (ADP-ribose) polymerase inhibitors (PARPis) are becoming increasingly meaningful in oncology, and their therapeutic drug monitoring (TDM) might be beneficial for patients. Several bioanalytical methods have been reported for PARPis quantification in human plasma, but advantages might be obtained using dried blood spot (DBS) as a sampling technique. Our aim was to develop and validate a liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for olaparib, rucaparib, and niraparib quantification in both human plasma and DBS matrices. Additionally, we aimed to assess the correlation between the drug concentrations measured in these two matrices. DBS from patients was obtained using Hemaxis DB10 for volumetric sampling. Analytes were separated on a Cortecs-T3 column and detected with electrospray ionization (ESI)-MS in positive ionization mode. Validation was performed according to the latest regulatory guidelines, in the range (ng/mL) 140-7000 for olaparib, 100-5000 for rucaparib, and 60-3000 for niraparib, within the hematocrit (Hct) range 29-45%. The Passing-Bablok and Bland-Altman statistical analyses revealed a strong correlation between plasma and DBS for olaparib and niraparib. However, due to the limited amount of data, it was challenging to establish a robust regression analysis for rucaparib. To ensure a more reliable assessment, additional samples are required. The DBS-to-plasma ratio was used as a conversion factor (CF) without considering any patient-related hematological parameters. These results provide a solid basis for the feasibility of PARPis TDM using both plasma and DBS matrices.
Language	English
Publishing date	2023-05-18
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527217-2
ISSN	1999-4923
ISSN	1999-4923
DOI	10.3390/pharmaceutics15051524
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Article ; Online: Therapeutic Monitoring of Palbociclib, Ribociclib, Abemaciclib, M2, M20, and Letrozole in Human Plasma: A Novel LC-MS/MS Method.

Posocco, Bianca / Zanchetta, Martina / Orleni, Marco / Gagno, Sara / Montico, Marcella / Peruzzi, Elena / Roncato, Rossana / Gerratana, Lorenzo / Corsetti, Serena / Puglisi, Fabio / Toffoli, Giuseppe

Therapeutic drug monitoring

2024

Abstract: Background: Therapeutic drug monitoring (TDM) using cyclin-dependent kinase inhibitors (CDK4/6is) is a novel approach for optimizing treatment outcomes. Currently, palbociclib, ribociclib, and abemaciclib are the available CDK4/6is and are primarily ... ...

Abstract	Background: Therapeutic drug monitoring (TDM) using cyclin-dependent kinase inhibitors (CDK4/6is) is a novel approach for optimizing treatment outcomes. Currently, palbociclib, ribociclib, and abemaciclib are the available CDK4/6is and are primarily coadministered with letrozole. This study aimed to develop and validate an LC-MS/MS method for the simultaneous analysis of CDK4/6is, 2 active metabolites of abemaciclib (M2 and M20), and letrozole in human plasma for use in TDM studies. Methods: Sample pretreatment comprised protein precipitation with methanol and dilution of the supernatant with an aqueous mobile phase. Chromatographic separation was achieved using a reversed-phase XBridge BEH C18 column (2.5 μm, 3.0 × 75 mm XP), with methanol serving as the organic mobile phase and pyrrolidine-pyrrolidinium formate (0.005:0.005 mol/L) buffer (pH 11.3) as the aqueous mobile phase. A triple quadrupole mass spectrometer was used for the detection, with the ESI source switched from negative to positive ionization mode and the acquisition performed in multiple reaction monitoring mode. Results: The complete validation procedure was successfully performed in accordance with the latest regulatory guidelines. The following analytical ranges (ng/mL) were established for the tested compounds: 6-300, palbociclib and letrozole; 120-6000, ribociclib; 40-800, abemaciclib; and 20-400, M2 and M20. All results met the acceptance criteria for linearity, accuracy, precision, selectivity, sensitivity, matrix effects, and carryover. A total of 85 patient samples were analyzed, and all measured concentrations were within the validated ranges. The percent difference for the reanalyzed samples ranged from -11.2% to 7.0%. Conclusions: A simple and robust LC-MS/MS method was successfully validated for the simultaneous quantification of CDK4/6is, M2, M20, and letrozole in human plasma. The assay was found to be suitable for measuring steady-state trough concentrations of the analytes in patient samples.
Language	English
Publishing date	2024-02-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	424443-6
ISSN	1536-3694 ; 0163-4356
ISSN (online)	1536-3694
ISSN	0163-4356
DOI	10.1097/FTD.0000000000001174
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Article ; Online: Association of ADME gene polymorphisms on toxicity to CDK4/6 inhibitors in patients with HR+ HER2- metastatic breast cancer.

Peruzzi, Elena / Gerratana, Lorenzo / Montico, Marcella / Posocco, Bianca / Corsetti, Serena / Bartoletti, Michele / Gagno, Sara / Orleni, Marco / De Mattia, Elena / Baraldo, Massimo / Cecchin, Erika / Puglisi, Fabio / Toffoli, Giuseppe / Roncato, Rossana

Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

2023 Volume 167, Page(s) 115479

Abstract: A wide interindividual variability in therapeutic response to cyclin-dependent kinases 4 and 6 inhibitors (CDKis) palbociclib, ribociclib and abemaciclib, among patients with HR+/HER2- metastatic breast cancer has been reported. This study explored the ... ...

Abstract	A wide interindividual variability in therapeutic response to cyclin-dependent kinases 4 and 6 inhibitors (CDKis) palbociclib, ribociclib and abemaciclib, among patients with HR+/HER2- metastatic breast cancer has been reported. This study explored the impact of genetic polymorphisms in ADME genes (responsible for drug absorption, distribution, metabolism, and elimination) on CDKis safety profiles in 230 patients. Selected endpoints include grade 3/4 neutropenia at day 14 of the first treatment cycle, early dose-limiting toxicities (DLTs), and dose reductions within the initial three cycles. Our analysis revealed associations between these endpoints and polymorphisms in CYP3A4, CYP3A5, ABCB1, and ABCG2 genes. Their impact on CDKis plasma concentrations (C
Language	English
Publishing date	2023-09-19
Publishing country	France
Document type	Journal Article
ZDB-ID	392415-4
ISSN	1950-6007 ; 0753-3322 ; 0300-0893
ISSN (online)	1950-6007
ISSN	0753-3322 ; 0300-0893
DOI	10.1016/j.biopha.2023.115479
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Article ; Online: Clinical impact of body mass index on palbociclib treatment outcomes and effect on exposure.

Roncato, Rossana / Peruzzi, Elena / Gerratana, Lorenzo / Posocco, Bianca / Nuzzo, Sofia / Montico, Marcella / Orleni, Marco / Corsetti, Serena / Bartoletti, Michele / Gagno, Sara / Canil, Giovanni / De Mattia, Elena / Angelini, Jacopo / Baraldo, Massimo / Puglisi, Fabio / Cecchin, Erika / Toffoli, Giuseppe

Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

2023 Volume 164, Page(s) 114906

Abstract: The impact of body mass index (BMI) on treatment outcomes in patients with cancer is gaining increasing attention given the limited data available. The aim of this study was to investigate the contribution of BMI on the safety and efficacy profile of ... ...

Abstract	The impact of body mass index (BMI) on treatment outcomes in patients with cancer is gaining increasing attention given the limited data available. The aim of this study was to investigate the contribution of BMI on the safety and efficacy profile of palbociclib in 134 patients with metastatic luminal-like breast cancer treated with palbociclib and endocrine therapy (ET). Normal-weight and underweight patients (BMI<25) were compared with overweight and obese (BMI≥25). Detailed clinical and demographic data were collected. Patients with a BMI<25 had a higher incidence of relevant-hematologic toxicities (p = 0.001), dose reduction events (p = 0.003), and tolerated lower dose intensities (p = 0.023) compared to patients with a BMI≥25. In addition, patients with a BMI<25 had significantly shorter progression-free survival (log-rank p = 0.0332). A significant difference was observed in the subgroup of patients for whom systemic palbociclib concentrations were available: patients with a BMI<25 had a 25% higher median minimum plasma concentrations (C
MeSH term(s)	Humans ; Female ; Body Mass Index ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Receptor, ErbB-2 ; Breast Neoplasms/pathology ; Treatment Outcome
Chemical Substances	palbociclib (G9ZF61LE7G) ; Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2023-06-07
Publishing country	France
Document type	Journal Article
ZDB-ID	392415-4
ISSN	1950-6007 ; 0753-3322 ; 0300-0893
ISSN (online)	1950-6007
ISSN	0753-3322 ; 0300-0893
DOI	10.1016/j.biopha.2023.114906
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Article ; Online: An Exceptional Response to Dostarlimab in Mismatch Repair Deficient, Microsatellite Instability-High and Platinum Refractory Endometrial Cancer.

Bartoletti, Michele / Giorda, Giorgio / Viel, Alessandra / Fornasarig, Mara / Zdjelar, Adrian / Segatto, Enrica / Sorio, Roberto / Corsetti, Serena / Scalone, Simona / Nicoloso, Milena Sabrina / Pivetta, Tania / Lucia, Emilio / Clemente, Nicolò / Palazzari, Elisa / Canzonieri, Vincenzo / Puglisi, Fabio

Current oncology (Toronto, Ont.)

2022 Volume 29, Issue 8, Page(s) 5209–5212

Abstract: Until recently, effective therapies for advanced endometrial cancer progressing to a platinum-based combination were lacking. In this setting, immunotherapy with anti PD-1/PDL-1 monoclonal antibodies is rising as a new paradigm in particular for patients ...

Abstract	Until recently, effective therapies for advanced endometrial cancer progressing to a platinum-based combination were lacking. In this setting, immunotherapy with anti PD-1/PDL-1 monoclonal antibodies is rising as a new paradigm in particular for patients with microsatellites instability/mismatch repair deficiency. In this case report, we describe an exceptional and rapid response to dostarlimab in a platinum refractory endometrial cancer patient with high disease burden harboring a mismatch repair deficiency.
MeSH term(s)	Antibodies, Monoclonal, Humanized ; Brain Neoplasms ; Colorectal Neoplasms ; DNA Mismatch Repair ; Endometrial Neoplasms/drug therapy ; Endometrial Neoplasms/genetics ; Female ; Humans ; Immune Checkpoint Inhibitors ; Microsatellite Instability ; Neoplastic Syndromes, Hereditary ; Platinum/therapeutic use ; Programmed Cell Death 1 Receptor
Chemical Substances	Antibodies, Monoclonal, Humanized ; Immune Checkpoint Inhibitors ; Programmed Cell Death 1 Receptor ; dostarlimab ; Platinum (49DFR088MY)
Language	English
Publishing date	2022-07-22
Publishing country	Switzerland
Document type	Case Reports ; Research Support, Non-U.S. Gov't
ZDB-ID	1236972-x
ISSN	1718-7729 ; 1198-0052
ISSN (online)	1718-7729
ISSN	1198-0052
DOI	10.3390/curroncol29080413
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Article ; Online: Mast cells and cancer.

Paolino, Giovanni / Corsetti, Paola / Moliterni, Elisa / Corsetti, Serena / Didona, Dario / Albanesi, Marcello / Mattozzi, Carlo / Lido, Paolo / Calvieri, Stefano

Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia

2017 Volume 154, Issue 6, Page(s) 650–668

Abstract: Mast cells (MCs) are a potent proangiogenic factor in tumors, they product several pro-angiogenic factors such as fibroblast growth factor 2 (FGF-2), vascular epithelial growth factor (VEGF), tryptase and chymase. Tryptase is a serine protease classified ...

Abstract	Mast cells (MCs) are a potent proangiogenic factor in tumors, they product several pro-angiogenic factors such as fibroblast growth factor 2 (FGF-2), vascular epithelial growth factor (VEGF), tryptase and chymase. Tryptase is a serine protease classified as α-tryptase and β-tryptase, both produced by MCs. Tryptase degrades the tissues, playing an important role in angiogenesis and in the development of metastases. Serum tryptase increases with age, with increased damage to cells and risk of developing a malignancy and it could be considered the expression of a fundamental role of MCs in tumor growth or, on the contrary, in the antitumor response. Many biomarkers have been developed in clinical practice for improving diagnosis and prognosis of some neoplasms. Elevated tryptase levels are found in subgroups of patients with haematologic and solid cancers. In the current review, we want to update the perspectives of tryptase as a potential biomarker in daily practice in different neoplasms.
MeSH term(s)	Animals ; Biomarkers, Tumor/metabolism ; Humans ; Mast Cells/metabolism ; Neoplasms/blood supply ; Neoplasms/diagnosis ; Neoplasms/pathology ; Neovascularization, Pathologic/pathology ; Prognosis ; Tryptases/metabolism
Chemical Substances	Biomarkers, Tumor ; Tryptases (EC 3.4.21.59)
Language	English
Publishing date	2017-11-30
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	604114-0
ISSN	1827-1820 ; 0026-4741 ; 0392-0488
ISSN (online)	1827-1820
ISSN	0026-4741 ; 0392-0488
DOI	10.23736/S0392-0488.17.05818-7
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Article ; Online: Human epidermal growth factor receptor-2 (HER2) is a potential therapeutic target in extramammary Paget's disease of the vulva.

Bartoletti, Michele / Mazzeo, Roberta / De Scordilli, Marco / Del Fabro, Anna / Vitale, Maria Grazia / Bortot, Lucia / Nicoloso, Milena Sabrina / Corsetti, Serena / Bonotto, Marta / Scalone, Simona / Giorda, Giorgio / Sorio, Roberto / Andreetta, Claudia / Meacci, Maria Luisa / De Vivo, Rocco / Fasola, Gianpiero / Sopracordevole, Francesco / Puglisi, Fabio

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

2020 Volume 30, Issue 11, Page(s) 1672–1677

Abstract: Background: Invasive vulvar Paget's disease with over-expression of the human epidermal growth factor receptor 2 (HER2) protein is potentially suitable for targeted therapy, especially in a metastatic setting where no effective treatments are available.! ...

Abstract	Background: Invasive vulvar Paget's disease with over-expression of the human epidermal growth factor receptor 2 (HER2) protein is potentially suitable for targeted therapy, especially in a metastatic setting where no effective treatments are available. Methods: Four consecutive patients with HER2 positive advanced vulvar Paget's disease, treated with weekly trastuzumab (loading dose 4 mg/kg, then 2 mg/kg) and paclitaxel (80 mg/m Results: Median age and follow-up of patients were 62.5 years (45-74) and 16 months (6-54), respectively. Complete or partial responses were observed in all patients. Median time to response was 3 months (range 2-4), while median duration of response was 10 months (range 2-34). Case 1 presented with pulmonary and lymph nodes involvement. She experienced a radiological complete response after 24 treatment administrations, and a progression-free survival of 36 months. At disease progression, treatment re-challenge achieved partial response. She is currently receiving treatment with trastuzumab-emtansine. Case 2 was a 74-year-old woman who developed pulmonary metastasis after first-line cisplatin treatment. She had a partial response and a progression-free survival of 10 months. Case 3 had inguinal and para-aortic lymphadenopathy in complete response after 18 treatment administrations. She developed brain metastasis while receiving trastuzumab maintenance. Case 4 was treated for locally advanced disease and experienced a subjective benefit with relief in perineal pain and itching. No unexpected treatment-related side effects were reported. Conclusions: Advanced vulvar Paget's disease is a rare disorder and no standard treatment is available. In the sub-group of HER2 positive disease, weekly paclitaxel-trastuzumab appears to be active and safe, and may be considered a therapeutic option in these patients.
MeSH term(s)	Adult ; Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Fatal Outcome ; Female ; Humans ; Middle Aged ; Neoplasm Recurrence, Local ; Off-Label Use ; Paclitaxel/administration & dosage ; Paclitaxel/adverse effects ; Paget Disease, Extramammary/drug therapy ; Paget Disease, Extramammary/pathology ; Receptor, ErbB-2/metabolism ; Trastuzumab/administration & dosage ; Trastuzumab/adverse effects ; Vulvar Neoplasms/drug therapy ; Vulvar Neoplasms/pathology
Chemical Substances	Antineoplastic Agents, Immunological ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) ; Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2020-09-30
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	1070385-8
ISSN	1525-1438 ; 1048-891X
ISSN (online)	1525-1438
ISSN	1048-891X
DOI	10.1136/ijgc-2020-001771
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Zs.A 3198: Show issues

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Article: Multicenter phase II trial of first-line docetaxel/gemcitabine in advanced breast cancer pretreated with adjuvant anthracyclines.

Vici, Patrizia / Giotta, Francesco / DI Lauro, Luigi / Brandi, Mario / Gebbia, Vittorio / Foggi, Paolo / Lorusso, Vito / Vitucci, Carlo / Sergi, Domenico / Fattoruso, Silvia Ileana / Giannarelli, Diana / Viola, Giuditta / Corsetti, Serena / Colucci, Giuseppe / Lopez, Massimo

Anticancer research

2009 Volume 29, Issue 5, Page(s) 1841–1845

Abstract: Unlabelled: The aim of this study was to evaluate activity and tolerability of docetaxel-gemcitabine combination as first-line treatment in patients with metastatic breast cancer previously treated with adjuvant anthracyclines.: Patients and methods: ...

Abstract	Unlabelled: The aim of this study was to evaluate activity and tolerability of docetaxel-gemcitabine combination as first-line treatment in patients with metastatic breast cancer previously treated with adjuvant anthracyclines. Patients and methods: Sixty-eight women received gemcitabine 1,000 mg/m(2) as 30-minute infusion on days 1 and 8, and docetaxel 80 mg/m(2) as 1-hour infusion on day 8, with cycles repeated every 3 weeks. Results: Objective responses were observed in 32 out of 68 evaluable patients (45%; 95% confidence interval, 35.2-58.8%). Responses were 44%, 42%, 49% in soft tissue, bone and visceral lesions, respectively, 50% /52% in HER2-positive/-negative tumors, and 50% in both ER- positive/-negative tumors. Median time to progression and overall survival were 6 and 16 months, respectively. Treatment was usually well tolerated, with grade 3-4 neutropenia in 32% - 7% of the patients, and neutropenic fever, grade 3 vomiting, mucositis and peripheral neurotoxicity in 3% of the patients. Conclusion: Gemcitabine-docetaxel combination is effective and well tolerated as first-line treatment in advanced breast cancer previously treated with adjuvant anthracyclines.
MeSH term(s)	Anthracyclines/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Breast Neoplasms/drug therapy ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Female ; Humans ; Taxoids/administration & dosage
Chemical Substances	Anthracyclines ; Taxoids ; Deoxycytidine (0W860991D6) ; docetaxel (15H5577CQD) ; gemcitabine (B76N6SBZ8R)
Language	English
Publishing date	2009-05
Publishing country	Greece
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study
ZDB-ID	604549-2
ISSN	1791-7530 ; 0250-7005
ISSN (online)	1791-7530
ISSN	0250-7005
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Article ; Online: A phase II trial of docetaxel and vinorelbine in patients with advanced breast cancer previously treated with anthracyclines.

Vici, Patrizia / Di Lauro, Luigi / Sergi, Domenico / Foggi, Paolo / Viola, Giuditta / Mottolese, Marcella / Giotta, Francesco / Fattoruso, Silvia I S / Corsetti, Serena / Giannarelli, Diana / Botti, Claudio / Lopez, Massimo

Oncology

2008 Volume 75, Issue 3-4, Page(s) 175–181

Abstract: Background: It was the aim of this study to evaluate the efficacy of docetaxel and vinorelbine combination in well-defined anthracycline-'exposed' or -'resistant' advanced breast cancer patients.: Patients and methods: A phase II trial was carried ... ...

Abstract	Background: It was the aim of this study to evaluate the efficacy of docetaxel and vinorelbine combination in well-defined anthracycline-'exposed' or -'resistant' advanced breast cancer patients. Patients and methods: A phase II trial was carried out enrolling 43 advanced breast cancer patients, all previously treated with anthracyclines, both in an adjuvant or advanced setting. Docetaxel 75 mg/m(2) as 1-hour infusion and vinorelbine 25 mg/m(2) as 30-min infusion were administered on day 1, every 3 weeks. Results: According to an intent-to-treat analysis, the response rate was 37.2% (95% CI 22.8-51.6) in 43 patients, whereas responses were observed in 16 (1 complete response, 15 partial response) out of 39 evaluable patients (41%, 95% CI 25.6-56.5); there were 50% with first-line and 33% with second-line therapy, and 50 and 29% of patients were considered anthracycline 'exposed' and 'resistant', respectively; responses by estrogen receptor (ER) status were given in 48% (ER positive) and 25% (ER negative), and by HER2 status, in 21% (HER2 positive) and 52% (HER2 negative). Median time to progression and median overall survival were 7.7 and 28.7 months, respectively. Toxicity was generally acceptable, with grade 3 neutropenia encountered in 15 (35%) patients and grade 4 neutropenia in 1 (2%) patient. Neutropenic fever occurred in 7 patients (16%), usually short-lasting. Grade 3 mucositis was encountered in 2 patients (5%). Conclusions: The combination of docetaxel and vinorelbine as a 3-weekly schedule is active and manageable in advanced breast cancer patients previously treated with anthracyclines.
MeSH term(s)	Adult ; Aged ; Anthracyclines/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bone Neoplasms/drug therapy ; Bone Neoplasms/secondary ; Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Neoplasm Staging ; Salvage Therapy ; Soft Tissue Neoplasms/drug therapy ; Soft Tissue Neoplasms/secondary ; Survival Rate ; Taxoids/administration & dosage ; Treatment Outcome ; Vinblastine/administration & dosage ; Vinblastine/analogs & derivatives
Chemical Substances	Anthracyclines ; Taxoids ; docetaxel (15H5577CQD) ; Vinblastine (5V9KLZ54CY) ; vinorelbine (Q6C979R91Y)
Language	English
Publishing date	2008
Publishing country	Switzerland
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	250101-6
ISSN	1423-0232 ; 0030-2414
ISSN (online)	1423-0232
ISSN	0030-2414
DOI	10.1159/000163056
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Article ; Online: A Phase II Trial of Docetaxel and Vinorelbine in Patients with Advanced Breast Cancer Previously Treated with Anthracyclines

Vici, Patrizia / Di Lauro, Luigi / Sergi, Domenico / Foggi, Paolo / Viola, Giuditta / Mottolese, Marcella / Giotta, Francesco / Fattoruso, Silvia I.S. / Corsetti, Serena / Giannarelli, Diana / Botti, Claudio / Lopez, Massimo

Oncology - International Journal of Cancer Research and Treatment

2008 Volume 75, Issue 3-4, Page(s) 175–181

Abstract: Background: It was the aim of this study to evaluate the efficacy of docetaxel and vinorelbine combination in well-defined anthracycline-‘exposed’ or -‘resistant’ advanced breast cancer patients. Patients and Methods: A phase II trial was carried out ... ...

Abstract	Background: It was the aim of this study to evaluate the efficacy of docetaxel and vinorelbine combination in well-defined anthracycline-‘exposed’ or -‘resistant’ advanced breast cancer patients. Patients and Methods: A phase II trial was carried out enrolling 43 advanced breast cancer patients, all previously treated with anthracyclines, both in an adjuvant or advanced setting. Docetaxel 75 mg/m2 as 1-hour infusion and vinorelbine 25 mg/m2 as 30-min infusion were administered on day 1, every 3 weeks. Results: According to an intent-to-treat analysis, the response rate was 37.2% (95% CI 22.8-51.6) in 43 patients, whereas responses were observed in 16 (1 complete response, 15 partial response) out of 39 evaluable patients (41%, 95% CI 25.6-56.5); there were 50% with first-line and 33% with second-line therapy, and 50 and 29% of patients were considered anthracycline ‘exposed’ and ‘resistant’, respectively; responses by estrogen receptor (ER) status were given in 48% (ER positive) and 25% (ER negative), and by HER2 status, in 21% (HER2 positive) and 52% (HER2 negative). Median time to progression and median overall survival were 7.7 and 28.7 months, respectively. Toxicity was generally acceptable, with grade 3 neutropenia encountered in 15 (35%) patients and grade 4 neutropenia in 1 (2%) patient. Neutropenic fever occurred in 7 patients (16%), usually short-lasting. Grade 3 mucositis was encountered in 2 patients (5%). Conclusions: The combination of docetaxel and vinorelbine as a 3-weekly schedule is active and manageable in advanced breast cancer patients previously treated with anthracyclines.
Keywords	Advanced breast cancer ; Chemotherapy ; Docetaxel ; Vinorelbine
Language	English
Publisher	S. Karger AG
Publishing place	Basel
Publishing country	Switzerland
Document type	Article ; Online
ZDB-ID	250101-6
ISSN	1423-0232 ; 0030-2414 ; 0030-2414
ISSN (online)	1423-0232
ISSN	0030-2414
DOI	10.1159/000163056
Database	Karger publisher's database

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