Full Oral Vinorelbine (NVBO) on D1 and D8 With Carboplatin
(CBDCA) as First Line Treatment in Advanced Non-small Cell Lung
Cancer (NSCLC) Patients: Preliminary Results of a Prospective
Study in Nonrandomized Population

a 2011

Full Oral Vinorelbine (NVBO) on D1 and D8 With Carboplatin (CBDCA) as First Line Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: Preliminary Results of a Prospective Study in Nonrandomized Population

SKŘIČKOVÁ, Jana, Marcela TOMÍŠKOVÁ, Lenka BABIČKOVÁ, Tereza JANASKOVA, Vítězslav KOLEK et. al.

Základní údaje

Originální název

Full Oral Vinorelbine (NVBO) on D1 and D8 With Carboplatin (CBDCA) as First Line Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: Preliminary Results of a Prospective Study in Nonrandomized Population

Autoři

SKŘIČKOVÁ, Jana (203 Česká republika, garant, domácí), Marcela TOMÍŠKOVÁ (203 Česká republika, domácí), Lenka BABIČKOVÁ (203 Česká republika, domácí), Tereza JANASKOVA (203 Česká republika), Vítězslav KOLEK (203 Česká republika), Jaromír ROUBEC (203 Česká republika) a Ivona GRYGARKOVA (203 Česká republika)

Vydání

Chest 2011 : Supplement, 2011

Další údaje

Jazyk

angličtina

Typ výsledku

Konferenční abstrakt

Obor

30200 3.2 Clinical medicine

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 5.250

Kód RIV

RIV/00216224:14110/11:00054050

Organizační jednotka

Lékařská fakulta

ISSN

DOI

http://dx.doi.org/10.1378/chest.1103753

Klíčová slova anglicky

Lung Cancer; Vinorelbine; Carboplatin

Změněno: 25. 11. 2011 13:32, Mgr. Michal Petr

Anotace

V originále

The purpose of this trial was to evaluate the activity and feasibility of CBDCA together with NVBO as first line treatment in patients with advanced NSCLC. METHODS: Patients with advanced NSCLC received NVBO 80 mg/m2 on D1 and D8 with CBDCA AUC5 on D1 every three weeks. In stage III, chemotherapy was followed by external radiotherapy. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test. RESULTS: 259 patients were treated: 209 men (80,7%) and 50 women (19,3%), median age 65 years. ECOG performance status at inclusion was PS 0 in 47 (18,2% patients, PS 1 in 185 (71,7%) and PS 2 in 26 (10,1%) patients. Most patients had stage IIIB 97 (37,5%) and stage IV NSCLC 130 (50,2%), only 32 (12,4%) were stage IIIA . Adenocarcinoma was confirmed in 52 patients (20,1%), squamous-cell carcinoma in 152 (58,7%), large-cell carcinoma in 8 (3,1%) and other in 47 (18,4%). Complete response was confirmed in 1 (0,4%) patient, partial response in 121 (46,7%), stable disease in 58 (22,4%), 79 (30,5%) patients progressed. The regimen was well tolerated. Median cycles was 4, the dosage of NVBO was without changes in 159 (61%) patients, the dosage of NVBO was reduced in 12 (4,7%) and escalated in 64 (24,8%). In 23 (8,9%) of patients was the dosage of NVBO reduced after escalation. Major toxicities (Grade 3-4) were neutropenia in 69 (26,9%), leucopenia in 51 (19,8%), anemia in 7 (2,7%), and thrombocytopenia in 6 (2,3%) patients. Febrile neutropenia was observed in 17 (6,6%) patients. Gastrointestinal toxicity grade 3-4 was observed in 47 (18,4%) patients. The estimated mOS was 13,8 moths. and the estimated mPFS was 9,4 months by median follow-up 8,5 months. The differences between groups of pts according to PS (0+1 vs. 2) were statistically significant (p < 0,001) better for patiens with PS 0+1. CONCLUSIONS: In this group of 259 non-selected patients with advanced NSCLC was the treatment with full NVBO and CBDCA in first line more convenient and well tolerated with evidence of high antitumour activity. This combination was active in all groups patients according histology.

Citovat

SKŘIČKOVÁ, Jana, Marcela TOMÍŠKOVÁ, Lenka BABIČKOVÁ, Tereza JANASKOVA, Vítězslav KOLEK, Jaromír ROUBEC a Ivona GRYGARKOVA. Full Oral Vinorelbine (NVBO) on D1 and D8 With Carboplatin (CBDCA) as First Line Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: Preliminary Results of a Prospective Study in Nonrandomized Population. In Chest 2011 : Supplement. 2011. ISSN 0012-3692. Dostupné z: https://dx.doi.org/10.1378/chest.1103753.

@proceedings{959102,
   author = {Skřičková, Jana and Tomíšková, Marcela and Babičková, Lenka and Janaskova, Tereza and Kolek, Vítězslav and Roubec, Jaromír and Grygarkova, Ivona},
   booktitle = {Chest 2011 : Supplement},
   doi = {http://dx.doi.org/10.1378/chest.1103753},
   keywords = {Lung Cancer; Vinorelbine; Carboplatin},
   language = {eng},
   title = {Full Oral Vinorelbine (NVBO) on D1 and D8 With Carboplatin (CBDCA) as First Line Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: Preliminary Results of a Prospective Study in Nonrandomized Population},
   year = {2011}
}

TY  - CONF
ID  - 959102
AU  - Skřičková, Jana - Tomíšková, Marcela - Babičková, Lenka - Janaskova, Tereza - Kolek, Vítězslav - Roubec, Jaromír - Grygarkova, Ivona
PY  - 2011
TI  - Full Oral Vinorelbine (NVBO) on D1 and D8 With Carboplatin (CBDCA) as First Line Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: Preliminary Results of a Prospective Study in Nonrandomized Population
KW  - Lung Cancer
KW  - Vinorelbine
KW  - Carboplatin
N2  - The purpose of this trial was to evaluate the activity and feasibility of CBDCA together with NVBO as first line treatment in patients with advanced NSCLC. METHODS: Patients with advanced NSCLC received NVBO 80 mg/m2 on D1 and D8 with CBDCA AUC5 on D1 every three weeks. In stage III, chemotherapy was followed by external radiotherapy. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test. RESULTS: 259 patients were treated: 209 men (80,7%) and 50 women (19,3%), median age 65 years. ECOG performance status at inclusion was PS 0 in 47 (18,2% patients, PS 1 in 185 (71,7%) and PS 2 in 26 (10,1%) patients. Most patients had stage IIIB 97 (37,5%) and stage IV NSCLC 130 (50,2%), only 32 (12,4%) were stage IIIA . Adenocarcinoma was confirmed in 52 patients (20,1%), squamous-cell carcinoma in 152 (58,7%), large-cell carcinoma in 8 (3,1%) and other in 47 (18,4%). Complete response was confirmed in 1 (0,4%) patient, partial response in 121 (46,7%), stable disease in 58 (22,4%), 79 (30,5%) patients progressed. The regimen was well tolerated. Median cycles was 4, the dosage of NVBO was without changes in 159 (61%) patients, the dosage of NVBO was reduced in 12 (4,7%) and escalated in 64 (24,8%). In 23 (8,9%) of patients was the dosage of NVBO reduced after escalation. Major toxicities (Grade 3-4) were neutropenia in 69 (26,9%), leucopenia in 51 (19,8%), anemia in 7 (2,7%), and thrombocytopenia in 6 (2,3%) patients. Febrile neutropenia was observed in 17 (6,6%) patients. Gastrointestinal toxicity grade 3-4 was observed in 47 (18,4%) patients. The estimated mOS was 13,8 moths. and the estimated mPFS was 9,4 months by median follow-up 8,5 months. The differences between groups of pts according to PS (0+1 vs. 2) were statistically significant (p < 0,001) better for patiens with PS 0+1. CONCLUSIONS: In this group of 259 non-selected patients with advanced NSCLC was the treatment with full NVBO and CBDCA in first line more convenient and well tolerated with evidence of high antitumour activity. This combination was active in all groups patients according histology.
ER  -

SKŘIČKOVÁ, Jana, Marcela TOMÍŠKOVÁ, Lenka BABIČKOVÁ, Tereza JANASKOVA, Vítězslav KOLEK, Jaromír ROUBEC a Ivona GRYGARKOVA. Full Oral Vinorelbine (NVBO) on D1 and D8 With Carboplatin (CBDCA) as First Line Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: Preliminary Results of a Prospective Study in Nonrandomized Population. In \textit{Chest 2011 : Supplement}. 2011. ISSN~0012-3692. Dostupné z: https://dx.doi.org/10.1378/chest.1103753.

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