Highlights
- •Nab-paclitaxel/carboplatin and gemcitabine/carboplatin had the same efficacy in advanced squamous cell lung carcinoma.
- •Both progression-free survival and overall survival had no difference between the two arms.
- •Both nab-PC and GC are well tolerated.
- •Nab-PC had advantage of improving quality of life.
Abstract
Background
Nab-paclitaxel/carboplatin (nab-PC) and gemcitabine/carboplatin (GC) are the standard first-line chemotherapy in
non–small cell lung carcinoma. Up to now, there is no head to head trial to compare
nab-PC with GC in advanced squamous cell lung carcinoma.
Patients and methods
A multicentre randomised phase II trial was performed to compare the efficacy and
safety for nab-PC with GC in previously untreated patients with advanced squamous cell lung carcinoma.
The primary end-point was objective response rate (ORR). Progression-free survival
(PFS), overall survival (OS), treatment-related adverse events and quality of life
(QoL) were also analysed.
Results
Totally 127 participants were eligible for this study (62/65 nab-PC/GC). Nab-PC has higher ORR than GC without statistical significance (42% versus 27%, P > 0.05). After a median follow-up of 14.5 months, both PFS and OS had no difference
between the two arms (6.7 versus 5.8 months, hazard ratio [HR] 0.75, P = 0.143; 11.6 versus 14.4 months, HR 0.92, P = 0.846). Both regimens were well tolerated; however, more dose reduction occurred
after cycle 2 in GC (27%) than in nab-PC (12%) (P < 0.05). Significant QoL improvement measured by trial outcome index was seen in
nab-PC than in GC (P < 0.05).
Conclusions
The first-line nab-PC and GC had the same response, PFS, and OS in patients with advanced squamous cell
lung carcinoma. Nab-PCM has advantage over GC in QoL improvement.
Trial registration number
NCT01236716.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to European Journal of CancerAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer.N Engl J Med. 2016; 375: 1823-1833
- Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer.N Engl J Med. 2018; 378: 2078-2092
- IMpower131: primary PFS and safety analysis of a randomized phase III study of atezolizumab + carboplatin + paclitaxel or nab-paclitaxel vs carboplatin + nab-paclitaxel as 1L therapy in advanced squamous NSCLC.J Clin Oncol. 2018; 36 (abstr LBA9000)
- Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer.N Engl J Med. 2018; 379: 2040-2051
- Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer.N Engl J Med. 2006; 355: 2542-2550
- BEYOND: a randomized, double-blind, placebo-controlled, multicenter, phase III study of first-line carboplatin/paclitaxel plus bevacizumab or placebo in Chinese patients with advanced or recurrent nonsquamous non-small-cell lung cancer.J Clin Oncol. 2015; 33: 2197-2204
- Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial.J Clin Oncol. 2012; 30: 2055-2062
- Safety and efficacy of weekly nab(R)-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer.Ann Oncol. 2013; 24: 314-321
- Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial.Lancet Oncol. 2015; 16: 763-774
- New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).Eur J Cancer. 2009; 45: 228-247
- What is a clinically meaningful change on the functional assessment of cancer therapy-lung (FACT-L) questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) study 5592.J Clin Epidemiol. 2002; 55: 285-295
- Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer.N Engl J Med. 2002; 346: 92-98
- Reliability and validity of the functional assessment of cancer therapy-lung (FACT-L) quality of life instrument.Lung Cancer. 1995; 12: 199-220
- Incidence of brain metastasis at the initial diagnosis of lung squamous cell carcinoma on the basis of stage, excluding brain metastasis.J Thorac Oncol. 2016; 11: 426-431
- Clinical predictors of metastatic disease to the brain from non-small cell lung carcinoma: primary tumor size, cell type, and lymph node metastases.Radiology. 2007; 242: 882-888
- A phase Ib study of pembrolizumab plus chemotherapy in patients with advanced cancer (PembroPlus).Br J Cancer. 2017; 117: 33-40
- nab-Paclitaxel potentiates gemcitabine activity by reducing cytidine deaminase levels in a mouse model of pancreatic cancer.Cancer Discov. 2012; 2: 260-269
- A phase II trial of albumin-bound paclitaxel and gemcitabine in patients with newly diagnosed PD-L1 IHC low/unknown stage IV squamous cell lung cancers.J Clin Oncol. 2018; 36e21035
- Cisplatin versus carboplatin in combination with third-generation drugs for advanced non-small cell lung cancer.Cochrane Database Syst Rev. 2013; CD009256
Article info
Publication history
Published online: February 07, 2019
Accepted:
January 7,
2019
Received in revised form:
December 14,
2018
Received:
October 19,
2018
Identification
Copyright
© 2019 Elsevier Ltd. All rights reserved.
