Phase II trial of weekly docetaxel and gemcitabine as first line therapy for patients with advanced non-small cell lung cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17076-17076 ◽  
Author(s):  
G. McNeill ◽  
S. Kalmadi ◽  
M. Davis ◽  
D. Peereboom ◽  
D. J. Adelstein ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Objective Response ◽  
Small Cell ◽  
Weekly Schedule ◽  
Small Cell Lung ◽  
Platinum Based Chemotherapy ◽  
Platinum Doublet

17076 Background: A platinum doublet has been the standard treatment for patients with advanced non-small cell lung cancer (NSCLC) and good performance status. This treatment results in almost a doubling of 1-year survival, along with an improvement in quality of life despite treatment related toxicities. However, platinum based treatment is associated with significant toxicity. Methods: In this trial, we prospectively evaluated a weekly regimen of docetaxel and gemcitabine for advanced NSCLC from December 2001 to January 2005. The endpoints of this study included objective response rate, survival and toxicity. Forty-two patients with previously untreated, advanced NSCLC with PS 0–1 were included. Patients received docetaxel (36 mg/m2) and gemcitabine (600 mg/m2) on days 1,8 and 15 of a 28-day cycle. Responses were assessed every two cycles. Results: The median age was 63 years; with 22 males and 20 females; 67% were >60 years old; and 38 patients had stage IV disease. In the intent-to-treat (ITT) analysis of response, 16 patients had a partial response (38%) and 15 patients had stable disease (36%). The 1-year survival was 48%; median survival for all patients was 11.3 months and the median progression-free survival was 5.1 months. Toxicities (> grade 3) included neutropenia (29%), asthenia (26%), thrombocytopenia (14%), diarrhea (14%), pneumonitis (7%), peripheral neuropathy (5%), peripheral edema (5%), nail changes (2%), and myositis (2%). Conclusions: This study demonstrated that this non-platinum doublet (docetaxel + gemcitabine) given on a weekly schedule for advanced NSCLC was well tolerated with efficacy comparable to platinum based chemotherapy regimens. [Table: see text]

Diagnostic and prognostic significance of circulating endothelial cell in advanced non-small cell lung cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18116-e18116
Author(s):  
Dongmei Yuan ◽  
Yanling Lv ◽  
Xingqun Ma ◽  
Hongbing Liu ◽  
Yi Shi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Objective Response ◽  
Prognostic Significance ◽  
Small Cell ◽  
Small Cell Lung ◽  
Platinum Based Chemotherapy ◽  
Nsclc Patients

e18116 Background: The aim of this study was to evaluate the diagnostic and prognostic value of circulating endothelial cells (CECs) during first-line therapy in patients with advanced non-small cell lung cancer (NSCLC). Methods: 102 newly diagnosed advanced NSCLC patients were enrolled in this study. The amount of CECs (CD45- CD31+ CD146+) was enumerated by flow cytometry at baseline and after two cycles of treatment. We correlated CEC counts and the reduction of CECs with objective response rate (ORR) and progression-free survival (PFS). Results: The CECs level was significantly higher in advanced NSCLC patients, ranging from 57 to 1300 cells/105 cells (n=102, mean±SD=299±221 cells/105 cells), than patients with benign lesions (n=35, 205±97 cells/105 cells), and healthy volunteers (n=34, 117±33 cells/105 cells). When the cut off value of CEC counts was 210 cells/105 cells, there was no significant association between CEC counts and OR/PFS of the enrolled patients. However, patients with CECs response after chemotherapy has more chances to achieve OR (P<0.001), and such patients showed longer PFS than those without CECs response (P = 0.041). In the multivariate analysis, the independent prognostic roles of performance status (HR: 3.245, 95% CI: 1.189-8.854), brain metastasis (HR: 3.673, 95% CI: 1.062-12.704), and CECs response (HR: 0.046, 95% CI: 0.188-0.984) were found. Conclusions: The CEC counts could be considered as the diagnostic biomarker for advanced NSCLC patients. And the reduction of CECs after treatment might be more ideal than the CEC counts as a predictive or prognostic factor in patients treated with platinum-based chemotherapy.

Pemetrexed Versus Pemetrexed and Carboplatin As Second-Line Chemotherapy in Advanced Non–Small-Cell Lung Cancer: Results of the GOIRC 02-2006 Randomized Phase II Study and Pooled Analysis With the NVALT7 Trial

2012 ◽  
Vol 30 (36) ◽  
pp. 4501-4507 ◽  
Author(s):  
Andrea Ardizzoni ◽  
Marcello Tiseo ◽  
Luca Boni ◽  
Andrew D. Vincent ◽  
Rodolfo Passalacqua ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Pooled Analysis ◽  
Small Cell ◽  
Second Line ◽  
Small Cell Lung ◽  
Platinum Based Chemotherapy ◽  
The Impact

Purpose To compare efficacy of pemetrexed versus pemetrexed plus carboplatin in pretreated patients with advanced non–small-cell lung cancer (NSCLC). Patients and Methods Patients with advanced NSCLC, in progression during or after first-line platinum-based chemotherapy, were randomly assigned to receive pemetrexed (arm A) or pemetrexed plus carboplatin (arm B). Primary end point was progression-free survival (PFS). A preplanned pooled analysis of the results of this study with those of the NVALT7 study was carried out to assess the impact of carboplatin added to pemetrexed in terms of overall survival (OS). Results From July 2007 to October 2009, 239 patients (arm A, n = 120; arm B, n = 119) were enrolled. Median PFS was 3.6 months for arm A versus 3.5 months for arm B (hazard ratio [HR], 1.05; 95% CI, 0.81 to 1.36; P = .706). No statistically significant differences in response rate, OS, or toxicity were observed. A total of 479 patients were included in the pooled analysis. OS was not improved by the addition of carboplatin to pemetrexed (HR, 90; 95% CI, 0.74 to 1.10; P = .316; P heterogeneity = .495). In the subgroup analyses, the addition of carboplatin to pemetrexed in patients with squamous tumors led to a statistically significant improvement in OS from 5.4 to 9 months (adjusted HR, 0.58; 95% CI, 0.37 to 0.91; P interaction test = .039). Conclusion Second-line treatment of advanced NSCLC with pemetrexed plus carboplatin does not improve survival outcomes as compared with single-agent pemetrexed. The benefit observed with carboplatin addition in squamous tumors may warrant further investigation.

Impact of Cancer Cachexia on Treatment With PD-1/PD-L1 Inhibitors Plus Chemotherapy in Advanced Non-small-Cell Lung Cancer

2021 ◽  
Author(s):  
Taichi Miyawaki ◽  
Tateaki Naito ◽  
Michitoshi Yabe ◽  
Hiroaki Kodama ◽  
Naoya Nishioka ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Cancer Cachexia ◽  
Advanced Nsclc ◽  
Group Performance ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung ◽  
The Impact

Abstract PurposeProgrammed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors plus chemotherapy has become the standard first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC). However, few studies have explicitly focused on the impact of cancer cachexia on the efficacy of PD-1/PD-L1 inhibitors plus chemotherapy. Thus, we evaluated the clinical implications of cancer cachexia on the survival outcomes in patients who received this treatment.MethodsWe conducted a retrospective review of medical records of patients with advanced NSCLC treated with PD-1/PD-L1 inhibitors plus chemotherapy from December 2018 to December 2020. Cancer cachexia was diagnosed as an unintentional weight loss of 5% or more over six months. We evaluated the progression-free survival (PFS) and overall survival (OS) for patients with or without cancer cachexia who received PD-1/PD-L1 inhibitors plus chemotherapy.ResultsAmong the 80 included patients, 37 (46%) had cancer cachexia. Cachectic patients had a lower objective response rate (30 vs 51%, P <0.05), poorer PFS (2.3 vs 12.0 months, P <0.05), and poorer OS (10.8 vs 23.9 months, P <0.05) than non-cachectic patients. The Cox proportional-hazard ratios (95% confidence interval) of cancer cachexia were 1.77 (1.01–3.10) for PFS and 2.90 (1.40–6.00) for OS, with adjustments for Eastern Cooperative Oncology Group performance status, PD-L1 tumour proportion score, histology, and central nervous system metastases. ConclusionPre-treatment cancer cachexia may reduce treatment efficacy and shorten survival time in patients receiving PD-1/PD-L1 inhibitors plus chemotherapy. Early evaluation and intervention for cancer cachexia might improve oncological outcomes in patients with advanced NSCLC.

Phase II Study of Weekly Nanoparticle Albumin-Bound Paclitaxel as Second- or Third-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer

Chemotherapy ◽  
2020 ◽  
Vol 65 (1-2) ◽  
pp. 21-28
Author(s):  
Mie Kotake ◽  
Tomohito Kuwako ◽  
Hisao Imai ◽  
Yoshio Tomizawa ◽  
Kyoichi Kaira ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Phase Ii Study ◽  
Performance Status ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung

Introduction: Treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) are poor due to limited treatment options. Objective: We conducted a multicenter, single-arm phase II study to prospectively assess the efficacy and safety of weekly nab-PTX in patients with advanced NSCLC with failed cytotoxic chemotherapy. Methods: Patients with advanced NSCLC having adequate organ functions with a performance status of 0–1 were enrolled. A 100 mg/m2 dose of nab-paclitaxel was administered on days 1, 8, and 15 of a 28-day cycle. Primary endpoint was the objective response rate (ORR). Secondary endpoints were disease control rate (DCR), toxicity profile, progression-free survival (PFS), and overall survival (OS). Results: Between September 2013 and May 2016, 35 patients were enrolled. The ORR was 31.4%, and the DCR was 74.3%. The median PFS was 3.6 months, and the median OS was 11.4 months. The most common grade 3 or 4 toxicities included neutropenia (54.3%), leukopenia (42.9%), and anemia (11.4%). Two patients discontinued chemotherapy due to pneumonitis. Conclusions: Nab-PTX may be a later-line chemotherapeutic option for previously treated advanced NSCLC.

scholarly journals Nivolumab plus Ipilimumab versus Existing Immunotherapies in Patients with PD-L1-Positive Advanced Non-Small Cell Lung Cancer: A Systematic Review and Network Meta-Analysis

Cancers ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 1905 ◽  
Author(s):  
Koichi Ando ◽  
Yasunari Kishino ◽  
Tetsuya Homma ◽  
Sojiro Kusumoto ◽  
Toshimitsu Yamaoka ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Meta Analysis ◽  
Small Cell ◽  
Outcome Analysis ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
Platinum Based Chemotherapy

No head-to-head trials have compared the efficacy and safety of nivolumab (Niv) plus ipilimumab (Ipi) combination therapy (Niv+Ipi) and existing regimens with immunotherapies approved as first-line treatment in patients with programmed cell death ligand 1 (PD-L1)-positive previously untreated advanced non-small cell lung cancer (NSCLC). We conducted a network meta-analysis of four relevant Phase Ⅲ trials to compare the efficacy and safety of Niv+Ipi, pembrolizumab (Pem) plus platinum-based chemotherapy (PBC) (Pem+PBC), Pem, Niv, or PBC using Bayesian analysis. The primary efficacy endpoint was progression-free survival (PFS) in patients with advanced NSCLC with PD-L1 expression ≥1%. The primary safety endpoint was the incidence of Grade 3–5 drug-related adverse events (G3–5AEs). Efficacy and safety were ranked using surface under the cumulative ranking curve (SUCRA). With regard to PFS, Niv+Ipi was inferior to Pem+PBC, and superior to Pem, Niv, or PBC alone. SUCRA ranking showed Pem+PBC had the highest efficacy for PFS, followed by Niv+Ipi, Niv, PBC, and Pem. The safety outcome analysis revealed Niv+Ipi was generally well tolerated compared to existing immunotherapy regimens. These results provide clinical information regarding the efficacy and safety of Niv+Ipi and indicate the possibility of the Niv+Ipi combination as a new therapeutic option in PD-L1-positive advanced NSCLC.

Circadian variation in nivolumab efficacy in patients with advanced non-small cell lung cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21585-e21585
Author(s):  
Abdoulaye Karaboué ◽  
Laurence Bisseux ◽  
Ida Pavese ◽  
Thierry Collon
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Objective Response ◽  
Circadian Variation ◽  
Indirect Evidence ◽  
Small Cell ◽  
Small Cell Lung ◽  
Significant Difference

e21585 Background: Despite efficacy of human checkpoint inhibitors, only 20 to 30% of treated patients present long term benefits. Circadian variations of the delivery of nivolumab to patients with advanced non-small-cell lung cancer (NSCLC) are proposed here as a factor potentially influencing the efficacy. Methods: A total of 1318 courses of nivolumab were administered in 57 consecutive patients with advanced NSCLC from September 2015 to December 2019 in Medical Oncology Unit of Montfermeil hospital. Percentage of total dose per patient delivered before and after 12:00 pm was computed and corelated to objective response rate (ORR), progression free survival (PFS) and overall survival (OS). Results: Twenty eight patients (49%) received ≥ 50% of their treatment before 12:00 pm (morning group) and 29 patients (51%) after 12:00 pm (afternoon group). ORR was 53.6% in morning group and 31.0% in afternoon group; p = 0.083. Both PFS and OS were significantly longer in morning group as compared to afternoon group. Median PFS was 18.6 months [95%CL, 8.6 – 28.7] and 3.5 months [2.9 – 4.1] in morning and afternoon group respectively; p < 0.001. After a maximum follow-up of 48 months, median OS was not reached in morning group whereas it was 14.4 months [0.0 – 29.5] in afternoon group; p = 0.004. Conclusions: The significant difference in the efficacy of nivolumab between morning and afternoon group is indirect evidence of the influence of circadian rhythm on the metabolism of this checkpoint inhibitor. The application of this finding in clinical practice should allow an increase of nivolumab efficacy in patients with advanced NSCLC.

The efficacy and safety profile of anlotinib plus docetaxel as second-line treatment in advanced non-small cell lung cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21068-e21068
Author(s):  
Zhiqiao Xu ◽  
Yan Zhang
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Objective Response ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Efficacy And Safety ◽  
Small Cell Lung

e21068 Background: Docetaxel is a standard second line treatment in advanced NSCLC, but the treatment effect is limited. Previous studies, such as REVEL, demonstrated that anti angiogenic therapy combined with docetaxel had significantly therapeutic efficacy. Anlotinib is an oral multi target angiogenesis TKI targeting the VEGFR, FGFR, PDGFR and c Kit. The ALTER 0303 trial showed that anlotinib improved both PFS and OS in later-line treatment for advanced NSCLC, and this study aims to investigate the efficacy and safety of Anlotinib combined with docetaxel in second-line treatment in advanced non-small cell lung cancer (NSCLC). Methods: This is a single-center, single-arm clinical trial. A group of 30 patients of histologically or cytologically confirmed, locally advanced stage IIIB-IV NSCLC and with ECOG PS 0-1 were admitted to the Kaifeng Central Hospital Cancer Center. Patients who progressed after first-line treatment were treated with anlotinib (12 mg p.o., QD d1 to 14, q3w) combined with docetaxel (75mg/m2, iv, QD, d1 to 14, q3w) as the second-line therapy. The primary endpoint was PFS. Secondary endpoints were OS, objective response rate (ORR), disease control rate (DCR) and safety. Results: A total of 30 patients were enrolled from October 2018 to April 2020. At data cutoff (Sept. 30, 2020), 30 patients were available for efficacy analysis. The median progression-free survival (mPFS) was 7.5 months (2.0-18.5). Among these patients, there was 1 CR, 9 PR, 15 SD, 5 PD, resulting in the ORR = 33.33% and the DCR = 83.33%. The Cox multivariate analysis showed that stage is an independent risk factor affecting prognosis ( p= 0.003). The most common grade 3 AEs were leukopenia (23,3%), neutropenia (13.3%), hypertension (13.3%), which can be controlled, and no grade 4 or grade 5 AEs occurred. Conclusions: Second line anlotinib plus docetaxel showed clinical benefit in advanced NSCLC patients in terms of PFS, ORR and DCR, and the incidence of adverse reactions are tolerable. This combination might be a promising option for patients advanced NSCLC.

Phase II Trial of Docetaxel and Vinorelbine in Patients With Advanced Non–Small-Cell Lung Cancer

2000 ◽  
Vol 18 (6) ◽  
pp. 1346-1350 ◽  
Author(s):  
Vincent A. Miller ◽  
Lee M. Krug ◽  
Kenneth K. Ng ◽  
Barbara Pizzo ◽  
Wendy Perez ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Single Agent ◽  
Objective Response ◽  
Dose Intensity ◽  
Small Cell ◽  
Small Cell Lung ◽  
Highly Active

PURPOSE: Docetaxel and vinorelbine are active agents in advanced non–small-cell lung cancer (NSCLC) and demonstrate preclinical synergism perhaps, in part, through their inactivation of the proto-oncogene bcl-2. We show that docetaxel (60 mg/m2) and vinorelbine (45 mg/m2) can be safely combined when given on an every 2-week schedule with filgrastim, with encouraging antitumor activity observed. PATIENTS AND METHODS: Thirty-five chemotherapy naïve patients with advanced NSCLC received vinorelbine as an intravenous push immediately followed by docetaxel as a 1-hour intravenous infusion once every 2 weeks. Prophylactic corticosteroids, ciprofloxacin, and filgrastim were used. RESULTS: We delivered median doses of 450 mg/m2 of vinorelbine and 600 mg/m2 of docetaxel. The major objective response rate was 51% (95% confidence interval [CI], 34% to 68%). With a median follow-up of 14 months, the predicted median survival time was 14 months, and the 1-year survival rate was 60% (95% CI, 44% to 80%). Febrile neutropenia occurred in five patients and five (1.3%) of 384 treatments. No dose-limiting neurotoxicity occurred. Symptomatic onycholysis and excessive lacrimation were observed after several months or more of therapy. CONCLUSION: Docetaxel 60 mg/m2 and vinorelbine 45 mg/m2, both given every 2 weeks, is a highly active combination for the treatment of advanced NSCLC. Filgrastim largely obviates neutropenic fever and allows for the single-agent dose-intensity of both drugs to be delivered. The occurrence of certain late toxicities can limit use in some cases and suggests that the combination could also be beneficial in settings requiring briefer, fixed periods of treatment, such as in induction or postoperative therapy.

scholarly journals Shenfu Injection Adjunct with Platinum-Based Chemotherapy for the Treatment of Advanced Non-Small-Cell Lung Cancer: A Meta-Analysis and Systematic Review

2017 ◽  
Vol 2017 ◽  
pp. 1-12 ◽  
Author(s):  
Ailing Cao ◽  
Hailang He ◽  
Mengxin Jing ◽  
Beibei Yu ◽  
Xianmei Zhou
Keyword(s):  
Lung Cancer ◽  
Adverse Effects ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Meta Analysis ◽  
Small Cell ◽  
Small Cell Lung ◽  
Shenfu Injection ◽  
Platinum Based Chemotherapy

Platinum-based chemotherapy is one of the standard treatments for non-small-cell lung cancer (NSCLC), while its high toxicity and limited clinical effects raise big concerns. Shenfu injection (SFI) has been commonly used as an adjutant chemotherapy drug for NSCLC in China. We ascertained the beneficial and adverse effects of SFI in combination with platinum-based chemotherapy for advanced NSCLC by using meta-analysis methods. The randomized controlled trials (RCTs) involving advanced NSCLC treatment with SFI plus platinum-based chemotherapy versus chemotherapy alone were searched on 6 medical databases up to February 2017. Cochrane handbook 5.1.0 was applied to assess the quality of included trials and RevMan 5.3 software was employed for data analysis. 23 RCTs including 1574 patients met our inclusion criteria. We evaluated the following outcome measures: objective tumor response (ORR), disease control rate (DCR), Karnofsky performance score (KPS), adverse effects, and indicators of cellular immune function. The meta-analysis indicated that SFI plus platinum-based chemotherapy may benefit the patients with NSCLC on attenuated synergies of chemotherapy. These findings need to be confirmed by further rigorously designed high-quality and large-scale RCTs.

Efficacy and Safety of Addition of Anti-PD1 to Chemotherapy in Treatment of Non-Small Cell Lung Cancer

2019 ◽  
Vol 21 (10) ◽  
pp. 711-717 ◽  
Author(s):  
Chu-Hui Ru ◽  
Yan-Bing Zhuang
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Large Scale ◽  
Advanced Nsclc ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung ◽  
Oncological Outcomes ◽  
Previously Treated

Background: Patients with previously treated non-small-cell lung cancer (NSCLC) have limited treatment options. A novel treatment based on programmed death 1 (PD-1)/programed death ligand 1 (PD-L1) inhibitors has emerged as promising therapeutic options for advanced NSCLC. We assessed oncological outcomes of PD-L1 antibody versus docetaxel in previously treated NSCLC. Objectives: The purpose of this meta-analysis was to analyse the oncological outcomes of anti-PD1 to chemotherapy in the treatment of non-small-cell lung cancer. Results: Overall survival (OR=0.68,95%CI=0.61-0.75, P<0.00001) and progression-free survival (OR=0.84,95%CI=0.77-0.92, P=0.0002) were longer with anti-PD1 than with docetaxel in NSCLC. Anti-PD1 was associated with even greater objective response rate than docetaxel (OR=1.61,95%CI=1.16-2.24, P=0.004). Treatment-related adverse events of grade 3-5 did favor anti-PD1 over docetaxel (OR=0.21,95%CI=0.10-0.42, P<0.00001). Conclusions: Among patients with advanced NSCLC, we found that there was a superior survival benefit and with a favorable safety profile with anti-PD1 than with docetaxel. More large-scale randomized controlled trials are needed to identify relevant biomarkers that have an effect on predicting the population that would most likely benefit from PD-1/PD-L1 for pretreated advanced NSCLC patients.

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