Randomized phase II trial of carboplatin + nab-paclitaxel versus cisplatin + gemcitabine for chemotherapy-naïve squamous cell carcinoma: North Japan lung cancer study group 1302.
Albumins
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Carboplatin
/ adverse effects
Carcinoma, Squamous Cell
/ drug therapy
Cisplatin
/ adverse effects
Deoxycytidine
/ analogs & derivatives
Humans
Japan
Lung Neoplasms
/ drug therapy
Paclitaxel
/ adverse effects
Treatment Outcome
Gemcitabine
Albumin-bound paclitaxel
Carboplatin
Chemotherapy
Cisplatin
Gemcitabine
Journal
International journal of clinical oncology
ISSN: 1437-7772
Titre abrégé: Int J Clin Oncol
Pays: Japan
ID NLM: 9616295
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
received:
11
07
2020
accepted:
29
10
2020
pubmed:
14
11
2020
medline:
24
2
2021
entrez:
13
11
2020
Statut:
ppublish
Résumé
A subset analysis of the CA031 trial showed significant improvement in the overall response rate after administration of carboplatin plus weekly albumin-bound paclitaxel compared to carboplatin plus paclitaxel for squamous cell carcinoma of the lung (SQ). We conducted this phase II study to compare carboplatin plus weekly albumin-bound paclitaxel (CnP) to cisplatin plus gemcitabine (CG), a standard regimen for SQ. Chemotherapy-naïve patients with SQ were randomly assigned to receive cisplatin (80 mg/m Between June 2013 and October 2018, 71 patients were enrolled and assigned to either the CG arm (n = 35) or the CnP arm (n = 36) of the study. The overall response rate was 43% [95% confidence interval (CI) 27.3-58.5] in the CG arm and 47% (95% CI 31.7-62.7) in the CnP arm. Although drug combination efficacies did not differ, there were differences in toxicity: hematologic toxicities (leukopenia, neutropenia, and thrombocytopenia) were found mostly in the CG arm, whereas anemia and sensory neuropathy were more common in the CnP arm. CnP had similar response as CG despite being a carboplatin-based regimen and toxicities differed between arms. Regarding ORR, CnP was comparable to CG for SQ.
Sections du résumé
BACKGROUND
BACKGROUND
A subset analysis of the CA031 trial showed significant improvement in the overall response rate after administration of carboplatin plus weekly albumin-bound paclitaxel compared to carboplatin plus paclitaxel for squamous cell carcinoma of the lung (SQ). We conducted this phase II study to compare carboplatin plus weekly albumin-bound paclitaxel (CnP) to cisplatin plus gemcitabine (CG), a standard regimen for SQ.
METHODS
METHODS
Chemotherapy-naïve patients with SQ were randomly assigned to receive cisplatin (80 mg/m
RESULTS
RESULTS
Between June 2013 and October 2018, 71 patients were enrolled and assigned to either the CG arm (n = 35) or the CnP arm (n = 36) of the study. The overall response rate was 43% [95% confidence interval (CI) 27.3-58.5] in the CG arm and 47% (95% CI 31.7-62.7) in the CnP arm. Although drug combination efficacies did not differ, there were differences in toxicity: hematologic toxicities (leukopenia, neutropenia, and thrombocytopenia) were found mostly in the CG arm, whereas anemia and sensory neuropathy were more common in the CnP arm.
CONCLUSIONS
CONCLUSIONS
CnP had similar response as CG despite being a carboplatin-based regimen and toxicities differed between arms. Regarding ORR, CnP was comparable to CG for SQ.
Identifiants
pubmed: 33184754
doi: 10.1007/s10147-020-01828-1
pii: 10.1007/s10147-020-01828-1
doi:
Substances chimiques
130-nm albumin-bound paclitaxel
0
Albumins
0
Deoxycytidine
0W860991D6
Carboplatin
BG3F62OND5
Paclitaxel
P88XT4IS4D
Cisplatin
Q20Q21Q62J
Gemcitabine
0
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
515-522Références
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