Efficacy and safety of oral etoposide maintenance therapy following cisplatin plus etoposide in advanced small cell lung cancers (Study of the Anatolian Society of Medical Oncology).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e18546-e18546
Author(s):  
Zuhat Urakci ◽  
Muhammet Ali Kaplan ◽  
Olcun Umit Unal ◽  
Mehmet Kucukoner ◽  
Alper Sevinc ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Performance Status ◽  
Progression Free Survival ◽  
Small Cell ◽  
Oral Etoposide ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
Ecog Performance Status ◽  
Lung Cancers ◽  
Grade 3

e18546 Background: Small cell lung cancers (SCLC) constitute a mean of 15% of lung cancers and present with advanced disease at time of diagnosis in 60% of cases. Cisplatin plus etoposide schedule is the standard treatment in these patients , whereas the role of maintenance therapy is debated. We assessed the efficacy and safety of oral etoposide maintenance therapy following cisplatin plus etoposide in advanced SCLC. Methods: Demographic features, treatment response, survival rate, and toxicity rate were assessed in our patients who were followed up for advanced SCLC between 2006 and 2012, had a ECOG performance status of 0-1, and were given oral etoposide maintenance therapy (50mg/day, given 14 days of a 21-day cycle, a total of 6 cycles) following 6 courses of cisplatin (75 mg/m2, 1 day) and etoposide (100mg/m2, 3 days). Results: A total of 51 patients were studied, 46 (90.2%) of whom were male; the mean age was 59 (28-78) years at diagnosis. Forty-four (86.2%) patients had partial remission while 7 (13.7%) had complete remission. Nine (17.6%) developed neutropenic fever while grade 3-4 toxicities, neutropenia, anemia, thrombocytopenia, neuropathy, diarrhea, nausea and vomiting were present in 39.2%, 9.8%, 5.9%, 1.9%, 3.9%, 3.9%, and 1.9% respectively. Chemotherapy was postponed in fourteen (27.4%) patients due to toxicity. Six (11.7%) patients taking oral etoposide developed febrile neutropenia and 3 (5.9%) developed grade 3-4 thrombocytopenia. Chemotherapy was postponed in 5 (9.8%) patients due to toxicity while no toxic death was observed. After a median follow-up of 19 months, 32 (62.7%) patients experienced progression of disease and 29 (56.8%) died. Median progression free survival was found 11.6 months (%95 CI; 10.2-12.9 months) and median overall survival was found 15.6 (%95CI; 11.5-19.7 months) months. Conclusions: Our results were similar with the previous literature. Oral etoposide maintenance therapy following cisplatin plus etoposide therapy in advanced SCLC is effective and tolerable. Further randomized studies are needed in this topic.

Phase II Trial of Gemcitabine in Refractory or Relapsed Small-Cell Lung Cancer: Eastern Cooperative Oncology Group Trial 1597

2003 ◽  
Vol 21 (8) ◽  
pp. 1550-1555 ◽  
Author(s):  
Gregory A. Masters ◽  
Lieven Declerck ◽  
Charles Blanke ◽  
Alan Sandler ◽  
Russell DeVore ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Small Cell ◽  
Oncology Group ◽  
Small Cell Lung ◽  
Ecog Performance Status ◽  
Grade 3

Purpose: Gemcitabine has shown a broad range of activity in solid tumors, including previously untreated small-cell lung cancer (SCLC). The objective of this phase II trial was to investigate the activity of gemcitabine in patients with relapsed SCLC. Patients and Methods: SCLC patients with measurable disease who had experienced treatment failure with one prior chemotherapy regimen were considered eligible. Patients were required to have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and adequate organ function; signed informed consent was also required. Treatment consisted of gemcitabine 1,000 mg/m2 on days 1, 8, and 15 of a 28-day cycle. Patients were stratified according to their previous response to first-line chemotherapy (primary refractory v primary sensitive disease). Results: Forty-six patients were enrolled onto this phase II trial (20 refractory and 26 sensitive patients). Forty-two of these patients were assessable for response and survival, and 44 were assessable for toxicity. Median patient age was 60 years, and median ECOG performance status was 1. Principal grade 3/4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (27%). The main grade 3/4 nonhematologic toxicities were pulmonary (9%) and neurologic toxicity (14%). Objective responses occurred in 11.9% of patients overall, including one patient with refractory SCLC (5.6%) and four patients with sensitive SCLC (16.7%). Median survival for the overall group was 7.1 months. Survival was not significantly different for patients with refractory versus sensitive disease. Conclusion: Gemcitabine has modest activity in previously treated SCLC patients. The favorable toxicity profile warrants further investigation, either in combination chemotherapy regimens or with targeted biologic compounds.

Irinotecan Plus Carboplatin Versus Oral Etoposide Plus Carboplatin in Extensive Small-Cell Lung Cancer: A Randomized Phase III Trial

2008 ◽  
Vol 26 (26) ◽  
pp. 4261-4267 ◽  
Author(s):  
Andreas Hermes ◽  
Bengt Bergman ◽  
Roy Bremnes ◽  
Lars Ek ◽  
Sverre Fluge ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Area Under The Curve ◽  
Small Cell ◽  
Phase Iii ◽  
Oral Etoposide ◽  
Small Cell Lung ◽  
Grade 3

Purpose A Japanese randomized trial showed superior survival for patients with extensive-disease (ED) small-cell lung cancer (SCLC) receiving irinotecan plus cisplatin compared with etoposide plus cisplatin. The present trial evaluated the efficacy of irinotecan plus carboplatin (IC) compared with oral etoposide plus carboplatin (EC). Patients and Methods Patients with ED SCLC were randomly assigned to receive either IC, which consisted of carboplatin (area under the curve = 4; Chatelut formula) and irinotecan (175 mg/m2) intravenously both on day 1, or EC, which consisted of carboplatin as in IC and etoposide (120 mg/m2/d) orally on days 1 through 5. Courses were repeated every 3 weeks with four cycles planned. Doses were reduced by one third in patients with a WHO performance status (PS) of 3 to 4 and/or age older than 70 years. Primary end point was overall survival (OS). Secondary end points were quality of life (QOL) and complete response (CR) rate. Results Of 220 randomly assigned patients, 209 were eligible for analysis (IC, n = 105; EC, n = 104). Thirty-five percent were older than 70 years, and 47% had a PS of 2 to 4. The groups were well balanced with respect to prognostic factors. OS was inferior in the EC group (hazard ratio = 1.41; 95% CI, 1.06 to 1.87; P = .02). Median survival time was 8.5 months for IC compared with 7.1 months for EC. One-year survival rate was 34% for IC and 24% for EC. CR was seen in 18 IC patients compared with seven EC patients (P = .02). There were no statistically significant differences in hematologic grade 3 or 4 toxicity. Grade 3 or 4 diarrhea was more common in the IC group. QOL differences were small, with a trend toward prolonged palliation with the IC regimen. Conclusion IC prolongs survival in ED SCLC with slightly better scores for QOL.

Phase II study of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination therapy (SOL+BV; SOLA) in patients with unresectable metastatic colorectal cancer (mCRC).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 611-611 ◽  
Author(s):  
Takeshi Kato ◽  
Tomohiro Nishina ◽  
Kentaro Yamazaki ◽  
Takayuki Yoshino ◽  
Yoshinori Miyata ◽  
...  
Keyword(s):  
Phase Ii ◽  
Tumor Regression ◽  
Performance Status ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
Prolonged Treatment ◽  
Efficacy And Safety ◽  
Resection Rate ◽  
Ecog Performance Status ◽  
Grade 3

611 Background: The results from a randomized phase II trial in the first-line treatment of mCRC indicated that SOL regimen (S-1, Oral Leucovorin; LV, and Oxaliplatin) had promising activity with well-tolerated toxicities compared to mFOLFOX6 (Ojima et al, ESMO 2011). The median progression-free survival (PFS) for SOL and mFOLFOX6 was 9.6 and 6.9 months, respectively (HR=0.83). We evaluated the efficacy and safety of adding BV to SOL regimen in this study. Methods: The inclusion criteria were; 1) histologically proven adenocarcinoma of colon or rectum, 2) age ≥ 20 years, 3) no prior treatment for metastatic disease, 4) at least one target lesion by RECIST ver1.0 criteria, 5) ECOG Performance Status 0-1. Patients (pts) received S-1 (40-60 mg bid) and LV (25 mg bid) orally for one week and L-OHP (85 mg/m2), and BV (5 mg/kg) on day 1, every 2 weeks. The primary endpoint was the response rate (RR). Results: From October 2009 to April 2010, 31 pts were enrolled, and 29 pts were regarded as the population of full analysis set. Present data included the results of efficacy and safety up to 24 cycles. RR assessed by the independent review committee was 86.2 % (CR: 0 pts, PR: 25 pts), and disease control rate (DCR) was 100%. The median PFS assessed by investigators was 12.5 months, while further follow up is ongoing. One year survival rate was 100%. The incidence of grade 3/4 adverse drug reactions were; neutropenia 16.7%, diarrhea 10.0%, hypertension 16.7%, and sensory neuropathy 53.3%. The median cumulative oxaliplatin dose was 915.0 mg/m2 (range 330-1735 mg/m2). The high prevalence of grade 3 neuropathy seemed due to the prolonged treatment duration. Reasons for discontinuation were progressive disease in 13 pts, and metastatectomy by tumor regression in 6 pts. The resection rate was 17.2 %. Conclusions: SOL+BV showed promising activity with high RR, DCR, PFS and resection rate with well tolerated toxicities in pts with unresectable mCRC. This trial was supported by Taiho Pharmaceutical CO.,LTD. (JAPIC Clinical Trials information Identifier: JapicCTI-090881).

Metronomic weekly paclitaxel in metastatic or recurrent non-small cell lung cancers.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19095-e19095 ◽  
Author(s):  
Nidhi Tandon ◽  
Vanita Noronha ◽  
Kumar Prabhash
Keyword(s):  
Performance Status ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Small Cell ◽  
Weekly Paclitaxel ◽  
Poor Performance Status ◽  
Motor Neuropathy ◽  
Small Cell Lung ◽  
Lung Cancers

e19095 Background: Metastatic non small cell lung cancer (NSCLC) has a median survival of 4 months in absence of therapy. We present our experience with metronomic weekly paclitaxel in patients with metastatic or recurrent NSCLC and those with poor performance status. Methods: This is a retrospective analysis of prospectively collected data of patients with metastatic or recurrent NSCLC without significant neuropathy who were heavily pretreated or platinum ineligible from Feb 2010 to Oct 2012 at our centre. Patients were treated with paclitaxel at 80 mg/m2 over 1 hour weekly and underwent regular follow up. Chemotherapy was discontinued on disease progression or intolerable side -effects or patients choice. Patients who received at least 4 cycles of chemotherapy were included in the analysis. Toxicity was graded according to CTCAEv4.03. Statistics were calculated using SPSSv18.0. The progression-free survival was calculated from date of start of paclitaxel till date of symptomatic deterioration, radiological progression or start of next line of therapy or death due to any cause. Overall survival was calculated from date of start of paclitaxel to the date of death due to any cause. Results: Of the 100 patients studied (median age = 57 y, range 29–77 y), 74% were males, 51% were smokers, 45% had comorbidities, 35% had PS>2 and 74% had adenocarcinoma. About 53% received >2 prior lines of chemotherapy. Patients received a mean of 16.9 cycles of paclitaxel (range 4-72) after which it was withheld in 63% due to PD (53% radiological, 10% clinical) and in 12% due to toxicity. The response rates were 37% (CR-3% and PR-34%) while 35% had SD. 9% required dose reduction while 32% had delay in dose administration. G.3 adverse events observed were 12%-anaemia, 10%-neutropenia, 2%-febrile neutropenia, 15%- sensory neuropathy and 4%-motor neuropathy. The median OS was 12 months while median PFS was 5 months. Conclusions: Weekly paclitaxel is a promising and well tolerated therapy for advanced NSCLC.

Combination chemotherapy with irinotecan and cisplatin in elderly patients (≥65 years) with extensive-disease small-cell lung cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18135-18135
Author(s):  
G. Lee ◽  
K. Kim ◽  
Y. Cho ◽  
H. Kim ◽  
I. Hwang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Elderly Patients ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Performance Status ◽  
Small Cell ◽  
Small Cell Lung ◽  
Ecog Performance Status ◽  
Grade 3

18135 Background: Combination chemotherapy with irinotecan and cisplatin is one of the standard treatments for patients with small-cell lung cancer (SCLC). In elderly patients, however, its efficacy and toxicity has not been well documented. In this Phase II study, we assessed the efficacy and toxicity of combination chemotherapy with irinotecan and cisplatin and examined whether advanced age compromises it in elderly patients with previously untreated extensive-disease small-cell lung cancer (ED-SCLC). Methods: In this study, 43 previously untreated elderly patients (65 years or older) with ED-SCLC were given combination chemotherapy consisting of irinotecan 60mg/m2 on days 1, 8 and 15 and cisplatin 60mg/m2 on days 1. The treatment was repeated every four weeks until patients completed the maximum six cycles. Results: Patients consisted of 34 men and 9 women, whose median age was 70 years (range 65 - 81 years). A complete response and a partial response were observed in 23.3% (10/43) and 58.1% (25/43), respectively. The overall response rate was 81.4% (95% C.I; 69.7 - 93.0%). The overall median survival was 10.3 months (range 7.8 - 12.7 months). The 1-year and 2- year survival rates were 31.8% and 3.4%, respectively. The median progression-free survival was 8.32 months (range 6.8 - 9.8 months). Major toxicities included neutropenia (grade 3 to 4, 55.9%), leukopenia (grade 3 to 4, 46.5%), infection (grade 3 to 4, 37.3%) and diarrhea (grade 3 to 4, 30.3%). Incidence of febrile neutropenia was significantly higher in patients with ECOG performance status 2 compared with ECOG performance 1 (70.7% vs. 5.2%; p < 0.001). There were two treatment related deaths in patients ECOG performance status 2. Conclusions: Our results indicate that combination chemotherapy with irinotecan and cisplatin is an effective treatment for elderly patients with ED-SCLC. However, physicians should be aware of the mortality and morbidity due to myelosuppression following this treatment in elderly ED-SCLC patients with ECOG performance status 2. No significant financial relationships to disclose.

Phase II study of docetaxel and cisplatin in advanced non-small-cell lung cancer.

1998 ◽  
Vol 16 (5) ◽  
pp. 1948-1953 ◽  
Author(s):  
J Zalcberg ◽  
M Millward ◽  
J Bishop ◽  
M McKeage ◽  
A Zimet ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3

PURPOSE Docetaxel (Taxotere, Rhone-Poulenc Rorer, Antony, France) and cisplatin are two of the most active single agents used in the treatment of non-small-cell lung cancer (NSCLC). A recently reported phase I study of the combination of docetaxel and cisplatin recommended a dose of 75 mg/m2 of both drugs every 3 weeks for subsequent phase II study. PATIENTS AND METHODS Eligible patients were aged 18 to 75 years with a World Health Organization (WHO) performance status < or = 2 and life expectancy > or = 12 weeks, with metastatic and/or locally advanced NSCLC proven histologically or cytologically. Patients were not permitted to have received prior chemotherapy, extensive radiotherapy, or any radiotherapy to the target lesion and must have had measurable disease. Concurrent treatment with colony-stimulating factors (CSFs) or prophylactic antibiotics was not permitted. Docetaxel (75 mg/m2) in 250 mL 5% dextrose was given intravenously (i.v.) over 1 hour immediately before cisplatin (75 mg/m2) in 500 mL normal saline given i.v. over 1 hour in 3-week cycles. Premedication included ondansetron, dexamethasone, promethazine, and standard hyperhydration with magnesium supplementation. RESULTS A total of 47 patients, two thirds of whom had metastatic disease, were entered onto this phase II study. The majority of patients were male (72%) and of good (WHO 0 to 1) performance status (85%). All 47 patients were assessable for toxicity and 36 were for response. Three patients were ineligible and eight (17%) discontinued treatment because of significant toxicity. In assessable patients, the overall objective response rate was 38.9% (95% confidence limits [CL], 23.1% to 56.5%), 36.1% had stable disease, and 25% progressive disease. On an intention-to-treat analysis, the objective response rate was 29.8%. Median survival was 9.6 months and estimated 1-year survival was 33%. Significant (grade 3/4) toxicities included nausea (26%), hypotension (15%), diarrhea (13%), and dyspnea mainly related to chest infection (13%). One patient experienced National Cancer Institute (NCI) grade 3 neurosensory toxicity after eight cycles. Grade 3/4 neutropenia was common and occurred in 87% of patients, but thrombocytopenia > or = grade 3 was rare (one patient). Significant (grade 3/4) abnormalities of magnesium levels were common (24%). Febrile neutropenia occurred in 13% of patients and neutropenic infection in 11%, contributing to two treatment-related deaths. No neutropenic enterocolitis or severe fluid retention was reported. CONCLUSION Compared with other active regimens used in this setting, the combination of docetaxel and cisplatin in advanced NSCLC is an active regimen with a similar toxicity profile to other combination regimens.

scholarly journals SURG-05. IDEAL TREATMENT REGIMEN FOR PATIENTS WITH ≥1 BRAIN METASTASIS FROM PRIMARY NON-SMALL-CELL LUNG CANCER – A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii204-ii204
Author(s):  
Karanbir Brar ◽  
Yosef Ellenbogen ◽  
Behnam Sadeghirad ◽  
Jiawen Deng ◽  
Winston Hou ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Targeted Therapies ◽  
Meta Analysis ◽  
Performance Status ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
China National Knowledge Infrastructure

Abstract BACKGROUND Brain metastases (BM) are common in non-small cell lung cancer (NSCLC). The aim of this study was to assess the comparative effectiveness of treatments for BM from NSCLC. METHODS We searched MEDLINE, EMBASE, Web of Science, ClinicalTrials.gov, CENTRAL and references of key studies for randomized controlled trials (RCTs) published until October 2018. We also searched the Chinese databases Wanfang Data, Wanfang Med Online, China National Knowledge Infrastructure, and Chongqing VIP Information for RCTs published until September 2019. Trials including &gt; 10 patients were selected. The primary outcomes were overall survival (OS) and intracranial progression-free survival (PFS). We used a frequentist random-effects model for network meta-analysis and assessed the certainty of evidence using the GRADE approach. RESULTS Among 8798 abstracts, 106 RCTs (9452 patients) met inclusion criteria. Median sample size was 67 (range 25-554). All trials included adult patients with histologically proven NSCLC and &gt;1 BM proven on CT/MRI. Of trials that reported performance status (e.g. ECOG or KPS, n=67), 63/67 excluded patients with non-favorable performance status. Interventions assessed included surgery, WBRT, SRS, targeted therapies (i.e. EGFR/ALK inhibitors), and chemotherapy. Compared to WBRT alone, several interventions demonstrated a statistically significant increase in median OS, including non-targeted chemotherapy + surgery (MD: 415.3 days, 95% CI: 31.3-799.4), WBRT + EGFRi (MD: 200.2 days, 95% CI:146.3-254.1), and EGFRi alone (MD: 169.7 days, 95% CI: 49.7-289.7). Among all interventions, only WBRT + EGFRi showed a significant improvement in median PFS (MD: 108.0 days, 95%CI: 48.5-167.5). CONCLUSIONS Our preliminary analyses indicate an OS and PFS benefit on the addition of EGFR inhibitors to WBRT for the treatment of BMs from NSCLC. Further analyses of hazard ratios for OS/PFS are underway, and subgroup analyses are planned. These data support the growing role of targeted therapies in the treatment of BMs, particularly in susceptible mutant tumours.

First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): Two-year update from CheckMate 9LA.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9000-9000
Author(s):  
Martin Reck ◽  
Tudor-Eliade Ciuleanu ◽  
Manuel Cobo ◽  
Michael Schenker ◽  
Bogdan Zurawski ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Performance Status ◽  
Objective Response ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Expression Level ◽  
First Line ◽  
Ecog Performance Status ◽  
Grade 3

9000 Background: In the randomized phase 3 CheckMate 9LA trial (NCT03215706), first-line NIVO + IPI combined with 2 cycles of chemo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) vs chemo alone (4 cycles). Clinical benefit was observed regardless of programmed death ligand 1 (PD-L1) expression level and histology. Here we report data with 2 years’ minimum follow-up from this study. Methods: Adult patients (pts) with stage IV / recurrent NSCLC, ECOG performance status ≤ 1, and no known sensitizing EGFR/ALK alterations were stratified by PD-L1 (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous) and were randomized 1:1 to NIVO 360 mg Q3W + IPI 1 mg/kg Q6W + chemo (2 cycles; n = 361) or chemo alone (4 cycles; n = 358). Pts with non-squamous NSCLC in the chemo-alone arm could receive pemetrexed maintenance. The primary endpoint was OS. Secondary endpoints included PFS and ORR by blinded independent central review, and efficacy by different PD-L1 levels. Safety was exploratory. Results: At a minimum follow-up of 24.4 months for OS (database lock: Feb 18, 2021), pts treated with NIVO + IPI + chemo continued to derive OS benefit vs chemo, with a median OS of 15.8 months vs 11.0 months, respectively (HR, 0.72 [95% CI, 0.61–0.86]); 2-year OS rates were 38% vs 26%. Median PFS with NIVO + IPI + chemo vs chemo was 6.7 months vs 5.3 months (HR, 0.67 [95% CI, 0.56–0.79]); 8% and 37% of pts who had disease progression received subsequent immunotherapy, respectively. ORR was 38% with NIVO + IPI + chemo vs 25% with chemo. Similar clinical benefit with NIVO + IPI + chemo vs chemo was observed in all randomized pts and across the majority of subgroups, including by PD-L1 expression level (Table) or histology. Any grade and grade 3–4 treatment-related adverse events were reported in 92% and 48% of pts in the NIVO + IPI + chemo arm vs 88% and 38% in the chemo arm, respectively. Conclusion: With 2 years’ minimum follow-up, first-line NIVO + IPI + chemo demonstrated durable survival and benefit versus chemo in pts with advanced NSCLC; no new safety signals were identified. Clinical trial information: NCT03215706. [Table: see text]

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