Phase II trial of irinotecan, carboplatin, and bevacizumab in patients with extensive-stage small cell lung cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18130-18130 ◽  
Author(s):  
D. R. Spigel ◽  
J. D. Hainsworth ◽  
D. A. Yardley ◽  
H. A. Burris ◽  
C. Farley ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Hematologic Toxicity ◽  
Small Cell Lung ◽  
Extensive Stage ◽  
Ecog Ps

18130 Background: Bevacizumab (B) improves survival when combined with chemotherapy in non-small cell lung cancer treatment. Our center previously studied the role of B as maintenance therapy in patients (pts) with limited-stage small cell lung cancer (SCLC). The present multicenter community-based trial was designed to examine the role of B and chemotherapy in previously untreated pts with extensive- stage SCLC (ES-SCLC). Methods: The primary endpoint is to assess the median time to progression (TTP). Eligibility criteria: untreated ES-SCLC, ECOG PS 0–1, measurable disease, and informed consent. Exclusion criteria: hemoptysis, brain metastases, and therapeutic anticoagulation. Treatment: irinotecan (I) 60 mg/m2 IV D1, 8, 15, and carboplatin (C) AUC=4 IV D1, and B 10 mg/kg IV D1 and 15 every 28D. Pts were restaged every 8 weeks. If no evidence of progressive disease (PD) after 4–6 cycles, pts received B x 6 months. This 2- stage trial was designed to achieve a 40% improvement in historical median TTP of 6 months. Results: 34 pts were enrolled from 2/06 to 12/06 (trial ongoing, n=50 planned). Data are available for 23 pts in this analysis. Baseline characteristics: median age 66 years; male/female, 52%/48%; and ECOG PS 0/1, 35%/65%. The objective response rate was 78% (95% CI 58%-90%), all partial responses. One pt had stable disease and no pts had PD. Four pts were not evaluable due to: comorbidity (off study), 2 pts; too early, 2 pts. With a median follow-up of 7 months, the median TTP and overall survival have not been reached. Grade (G) 3/4 non-hematologic toxicity: diarrhea (26%), hyponatremia, pain, arthralgia, fatigue (13% each), and dehydration, confusion, proteinuria (9% each). G3/4 hematologic toxicity was limited to neutropenia (13%). Other G3/4 toxicities were = 5%. There have been no episodes of G3/4 bleeding or treatment-related deaths. Conclusions: I/C/B appears to be safe and generally well tolerated in pts with ES-SCLC in this preliminary analysis. Further accrual and longer follow-up are necessary to assess median TTP. No significant financial relationships to disclose.

Phase II trial of satraplatin and paclitaxel in the first-line treatment of advanced non-small cell lung cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18073-18073
Author(s):  
D. Shipley ◽  
D. R. Spigel ◽  
C. Cavanaugh ◽  
Y. Moore ◽  
J. D. Hainsworth ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Hematologic Toxicity ◽  
Combination Regimen ◽  
Newly Diagnosed ◽  
Small Cell Lung ◽  
Ecog Ps

18073 Background: Satraplatin (S) is a novel oral platinum analogue that has shown promising activity in a number of solid tumor settings. Our center previously conducted a phase I trial combining S and paclitaxel (P) in patients (pts) with refractory malignancies, establishing safety for this combination. This single center community-based trial was designed to examine the role of S/P in pts with newly diagnosed advanced non-small cell lung cancer (NSCLC). Methods: The primary endpoint is the objective response rate (ORR). Eligibility criteria: newly diagnosed and unresectable stage IIIB/IV NSCLC, measurable disease, ECOG PS 0–2, and informed consent. Treatment: S 80 mg/m2 PO days 1–5 and P 200mg/m2 IV day 1, every 28 days for a maximum of 6 cycles. Pts were restaged every 8 weeks. Results: 28 pts were enrolled from 2/06 to 12/06 (trial ongoing, n = 40 planned). Data are available on 24 pts for analysis. Baseline characteristics: median age 67 years; male/female, 58%/42%; and ECOG PS 0/1/2, 25%/63%/12%; adenocarcinoma/squamous/large cell/unspecified, 33%/42%/1%/24%. The ORR was 17% (95% CI 5%-37%). 10 pts (42%) had stable disease (SD) and 5 pts (21%) had progressive disease. The disease control rate (ORR + SD) was 59%. 5 pts were not evaluable due to: death (3 pts - 1 possibly due to treatment- related sepsis), and physician/pt preference (1 pt each). With a median follow-up of 8.3 months, the median time to progression is 4 months. Grade (G) 3/4 non-hematologic toxicity occurring in = 5%: infection (29%), nausea, vomiting (17% each), anorexia, hyperglycemia (13% each), and fatigue (8%). G3/4 hematologic toxicity: leukopenia (21%), neutropenia (41%), and thrombocytopenia (29%). Conclusions: In this preliminary analysis, S/P appears to have comparable activity to other platinum-based regimens. In an effort to reduce myelosuppression this trial has been amended to a S dose of 70 mg/m2. Additional accrual and follow-up are needed to better assess the safety and efficacy of this combination regimen. No significant financial relationships to disclose.

Irinotecan (I), carboplatin (C), and radiotherapy (RT) followed by maintenance bevacizumab (B) in the treatment (tx) of limited-stage small cell lung cancer (LS-SCLC): Update of a phase II trial of the Minnie Pearl Cancer Research Network

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7085-7085 ◽  
Author(s):  
J. F. Patton ◽  
D. R. Spigel ◽  
F. A. Greco ◽  
W. H. Liggett ◽  
J. D. Zubkus ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Progression Free Survival ◽  
Small Cell ◽  
Research Network ◽  
Colon Perforation ◽  
Hematologic Toxicity ◽  
Small Cell Lung ◽  
Ecog Ps

7085 Background: Targeting VEGF has proven to be an effective tx strategy in many solid tumors including non-small cell lung cancer. VEGF expression in SCLC provides rationale for studying B in addition to chemoradiotherapy. Methods: The endpoints of this multicenter community-based study were to assess the safety, response rate (RR), and progression-free survival (PFS) of I/C/RT followed by B in patients (pts) with LS-SCLC. Tx included: C AUC = 5 IV D1, I 50mg/m2 IV D1,8 Q 21D x 4 cycles, and RT 1.8 Gy daily to a total of 61.2 Gy, beginning with the 3rd cycle. 3rd and 4th cycles were 28D each. Pts were restaged after 4 cycles. If no progressive disease (PD) pts received B 10 mg/kg IV Q 14D x 10 doses. Eligibility included: measurable disease, ECOG PS 0–1, informed consent, and no new brain metastases or bleeding. Results: Fifty-seven pts were enrolled from 8/03 to 10/04. Forty-five pts (79%) and 41 pts (72%) received planned tx with I/C/RT and B, respectively. The range of follow-up is 14–28 months. Baseline features: median age 65 years (42–80); male/female, 37%/63%; ECOG PS 0,1: 26%/74%. Grade (G) 3/4 non-hematologic toxicity: diarrhea (9%), DVT (4%), vomiting (11%), and fatigue (9%). G3/4 hematologic toxicity: neutropenia (37%), anemia (5%), and thrombocytopenia (13%). Only 9% of pts experienced G3/4 toxicity during B tx (1 pt each: DVT, hypokalemia, depression, pain, and colon perforation). There were 2 tx-related deaths (both from respiratory failure; 1 and 2 doses of B had been administered). Complete/partial responses were observed in 15 pts (26%)/31 pts (54%), respectively, for an overall RR of 80% (95% CI 70%-90%). Four pts had stable disease, and 5% had PD (4 pts were unevaluable.) 1- and 2-year PFS rates were 63% and 54%, respectively. 1- and 2- year overall survival (OS) rates were 71% and 29%, respectively. Median OS was 15 months. Conclusions: The safety, RR, and 1- and 2-year survival results of I/C/RT followed by B compare favorably with standard tx for LS-SCLC; and B may improve PFS. Assessing the role of B as maintenance tx in improving OS in this setting will require randomized trials. [Table: see text]

scholarly journals Role of thoracic radiotherapy in extensive stage small cell lung cancer: a systemic review and meta-analysis

2021 ◽  
Vol 9 (4) ◽  
pp. 299-299
Author(s):  
Ao-Mei Li ◽  
Han Zhou ◽  
Yang-Yang Xu ◽  
Xiao-Qin Ji ◽  
Tian-Cong Wu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Meta Analysis ◽  
Small Cell ◽  
Systemic Review ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung ◽  
Extensive Stage

scholarly journals The Role of Immunotherapy in Extensive Stage Small-Cell Lung Cancer: A Review of the Literature

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Ioanna Tsiouprou ◽  
Athanasios Zaharias ◽  
Dionisios Spyratos
Keyword(s):  
Lung Cancer ◽  
Monoclonal Antibody ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Platinum Based Chemotherapy ◽  
Response To Chemotherapy ◽  
Extensive Stage

Lung cancer is the second most common cancer in both sexes worldwide. Small-cell lung cancer (SCLC) is a form of neuroendocrine tumor, which is classified into limited and extensive-stage disease and shows excellent initial response to chemotherapy; however, almost all patients relapse later. During the past few years, several clinical trials have evaluated the effect of addition of immunotherapy to conventional chemotherapy in patients with extensive SCLC. Checkpoint inhibitors are currently under investigation, especially the CTLA-4 and PD-1/PD-L1 inhibitors. Nowadays, evidence show a statistically significant survival benefit of adding atezolizumab, an IgG1 monoclonal antibody targeting against PD-L1, to platinum-based chemotherapy plus etoposide in patients who have not received any previous systemic therapy. Furthermore, the role of nivolumab, an IgG4 anti-PD-1 monoclonal antibody, is significant for the treatment of relapsed SCLC cases. Recently, pembrolizumab was the first immunotherapeutic agent to be approved by the FDA for patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of chemotherapy. Nevertheless, prognostic biomarkers to immunotherapy response remain to be discovered.

scholarly journals Prolonging Survival: The Role of Immune Checkpoint Inhibitors in the Treatment of Extensive‐Stage Small Cell Lung Cancer

2020 ◽  
Vol 25 (11) ◽  
pp. 981-992
Author(s):  
Barbara Melosky ◽  
Parneet K. Cheema ◽  
Anthony Brade ◽  
Deanna McLeod ◽  
Geoffrey Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Small Cell ◽  
Small Cell Lung ◽  
Extensive Stage
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