VP-16-213 in combination chemotherapy with chest irradiation for small-cell lung cancer: a randomized trial of the Piedmont Oncology Association.

1984 ◽  
Vol 2 (12) ◽  
pp. 1343-1351 ◽  
Author(s):  
D V Jackson ◽  
P J Zekan ◽  
R D Caldwell ◽  
M L Slatkoff ◽  
R W Harding ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Randomized Trial ◽  
Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Small Cell ◽  
Small Cell Lung ◽  
Limited Disease ◽  
Extensive Disease ◽  
Chest Irradiation

The role of etoposide epipodophyllotoxin (VP-16-213) in a combined modality treatment program incorporating local chest irradiation and combination chemotherapy with cyclophosphamide, Adriamycin (Adria Laboratories, Columbus, Ohio), and vincristine has been evaluated in a randomized trial of 165 patients with small-cell lung cancer. The overall response rate (complete response [CR] plus partial response [PR]) was significantly greater in the VP-16-213 arm (85% v 64%, P = .005) primarily as a consequence of improved response in patients with extensive disease (85% v 38%, P = .002 and 30% v 8% for CR only, P = .045). No differences in the response rates were observed in limited disease. The duration of response (months) was greater in the VP-16-213 arm (8.6 v 7.0 overall and 14.4 v 11.5 for CR) but not significantly so. Median survival times (months) were consistently greater in the group receiving VP-16-213 when analyzed according to extent of disease and response (10.6 v 9.5 overall; 15.0 v 13.6 for limited disease; 9.0 v 6.7 for extensive disease; 18.5 v 16.2 for CR overall; and 18.6 v 16.1 for CR in limited disease); the results were not statistically significant. The median survival of extensive disease patients attaining a CR was 15.3 months (range 3.2 to 34.3 + months) in the VP-16-213 arm and 7.4+ and 8.1+ months for the two patients with CR in the other group. Anemia and leukopenia occurred to a greater degree in the four-drug regimen, but no unusual or significant compounding toxicity (ie, neurotoxicity) was observed otherwise. Further investigation of this agent in combination chemotherapy programs for small-cell lung cancer appears to be warranted.

Cisplatin/etoposide versus ifosfamide/etoposide combination chemotherapy in small-cell lung cancer: a multicenter German randomized trial.

1987 ◽  
Vol 5 (12) ◽  
pp. 1880-1889 ◽  
Author(s):  
M Wolf ◽  
K Havemann ◽  
R Holle ◽  
C Gropp ◽  
P Drings ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Progression Free Survival ◽  
Skin Lesions ◽  
Small Cell ◽  
Small Cell Lung ◽  
Limited Disease ◽  
Extensive Disease

A total of 144 patients with small-cell lung cancer (SCLC) were randomized to receive cisplatin/etoposide (PE) or ifosfamide/etoposide (IE) combination chemotherapy. PE consisted of cisplatin, 80 mg/m2, intravenously (IV) on day 1, and etoposide, 150 mg/m2, IV on days 3 through 5. IE consisted of ifosfamide, 1,500 mg/m2, IV on days 1 through 5, and etoposide, 120 mg/m2, IV on days 3 through 5. Six cycles were administered in 3-week intervals. Nonresponders were switched immediately to CAV, consisting of cyclophosphamide, 600 mg/m2, IV on days 1 and 2, Adriamycin (Adria Laboratories, Columbus, OH), 50 mg/m2, IV on day 1, and vincristine, 2 mg, IV on day 1. Patients obtaining complete remission (CR) received prophylactic cranial irradiation with 30 Gy. After completion of chemotherapy, patients with limited disease received chest irradiation with 45 Gy. No maintenance therapy was given to patients in CR. Minimum follow-up was 2 years. Of the 141 patients evaluable, the overall response rate was 65% in PE therapy and 68% in IE therapy. The CR rate was 32% v 20% for all patients, 50% v 24% for limited disease, and 22% v 18% for extensive disease, all in favor of PE therapy. Median survival for all patients was 11.6 months v 9.4 months, for limited disease 14.8 months v 11.0 months, and for extensive disease 8.9 months v 7.5 months, all preferring PE therapy. The 2-year survival rate was higher in PE therapy than in IE therapy for all patients (12% v 9%) and for limited disease (23% v 10%), but not for extensive disease (5% v 9%). Median progression-free survival was 7.5 months v 6.0 months for all patients, 12.2 months v 8.8 months for limited disease, and 5.9 months v 4.4 months for extensive disease, all in favor of PE. Relapse in the area of the primary tumor was found less often after PE than after IE therapy (25% v 38%). Response to second-line CAV was seen in 30% of patients with prior PE and 43% with prior IE therapy, but was usually short lasting, and only one patient achieved CR. Toxicity included three lethal complications. Nausea, vomiting, diarrhea, and skin lesions occurred more often after PE than after IE therapy. These results suggest that PE is superior to IE chemotherapy in limited-stage, but not in extensive-stage SCLC, and that CAV is cross-resistant to PE, as well as to IE in the majority of patients.

Results of a Combined Chemo-Radiotherapeutic Program in 61 Patients Affected by Small Cell Lung Cancer

1988 ◽  
Vol 74 (2) ◽  
pp. 207-211
Author(s):  
Diego Tummarello ◽  
Francesco Guidi ◽  
Emilio Porfiri ◽  
Pierpaolo Isidor ◽  
Marzio Raspugli ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Median Survival ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Limited Disease ◽  
Extensive Disease ◽  
Who Grade ◽  
Term Survival

Sixty-one patients affected by small cell lung cancer (SCLC) entered in the study. Eighteen had limited disease and 43 extensive disease. Treatment consisted of: induction chemotherapy with 3 courses of CAV (cyclophosphamide, adriamycin, vincristine) in limited disease patients or 2 courses of CAV plus 2 courses of DDP-VP16 (cisplatin, etoposide) in extensive disease patients, followed by chest radiotherapy and CNS prophylaxis in responsive patients. Subsequently, responders and stable patients received maintenance chemotherapy by the alternation of cycles of CAV, DDP-VP16 and C'MP (CCNU, methotrexate, procarbazine), which lasted 1 year or until relapse. Four of 17 limited disease patients (23%) obtained a CR and 11 (65%) a PR; their median survival was 11 months (range, 2 + - 36 +). One of the 7 extensive disease patients (3%) achieved a CR and 19 (51%) a PR; their median survival was 6 months (range, 1-22). Median duration of response was 12 months for CR and 5 months for PR. Responders (CR and PR) survived 11.5 months versus 3.5 months for failures (P < 0.05); 3/61 (5%) showed long-term survival, in the absence of disease. The overall median survival was 7 months (range, 1-36 +). The main toxic effects were myelosuppression and vomiting (WHO grade 3). From our results, this program does not offer further substantial gains in patients with SCLC.

Real-world data in limited-disease small-cell lung cancer: Results from a retrospective nationwide population-based cohort study in Korean HIRA database.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21096-e21096
Author(s):  
Seoree KIM ◽  
In-Ho Kim ◽  
Ji Hyung Hong ◽  
Soo-Yoon Sung ◽  
Yeo Hyung KIM ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Cohort Study ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Small Cell ◽  
Small Cell Lung ◽  
Limited Disease ◽  
Platinum Resistant ◽  
Resistant Group

e21096 Background: Small cell lung cancer (SCLC) is a highly proliferative and rapidly growing tumor with poor prognosis, even in limited disease (LD), and a timely and accurately high intensity therapy is necessary. During the concurrent chemoradiotherapy (CCRT), etoposide with platinum (EP) regimen is recommended, however, irinotecan with cisplatin (IP) regimen is also effective. Therefore, we performed a large-scale, retrospective and nationwide cohort study to analyze the efficacy of CCRT in patients with LD-SCLC Methods: The population data were extracted from the Health Insurance Review and Assessment Service of Korea database from January 1, 2008, to November 30, 2016. Among 14,490 patients with SCLC patients who received chemotherapy, a total of 4,496 patients with LD-SCLC were analyzed. The primary objectives were to evaluate the survival outcomes of CCRT for LD-SCLC. Results: Patients who received EP-CCRT (n = 4,187) had better PFS of 11.233 months (95% confidence interval (CI) 10.900 – 11.667, P = 0.0477) and prolonged OS of 22.233 months (95% CI 21.233 – 23.333, P < 0.0001) than those who received IP-CCRT (n = 259; PFS = 9.567 months, 95% CI = 8.500 – 10.667; OS = 16.433 months, 95% CI = 14.467 – 18.333; P = 0.0477). After the failure of CCRT, we observed that dual chemotherapy (n = 925; OS = 9.133 months, 95% CI = 8.400 - 10.100) has better survival benefit (P < 0.0001) than single agent chemotherapy (n = 815; OS = 7.500 months, 95% CI, 6.933 – 8.133). IP chemotherapy demonstrated a better OS (9.567 months, 95% CI, 8.667 – 10.333 vs. 7.100 months, 95% CI, 5.100 – 10.400, P = 0.0170, respectively) than EP regimen in the platinum-resistant group; patients with PFS within 6 months after CCRT. However, in platinum sensitive group; patients who recurred after 6 months, the clinical benefit of EP regimen was superior to IP regimen (OS = 17.183 months, 95% CI, 13.033 – 25.633 vs. 6.617 months, 95% CI, 5.433 – 7.767; P < 0.0001). Cox proportional hazards regression analysis demonstrated that age, EP-CCRT, and dyslipidemia retained significant associations with OS after adjusting for all variables. Conclusions: In Korean population, concurrent thoracic radiotherapy with EP regimen had significantly favorable effects on OS and PFS. In addition, after the failure of CCRT, combination chemotherapy had clinical benefits over single agents. Among combination chemotherapy, IP combination regimen showed significantly favorable effects on OS and PFS, especially in the platinum-resistant group.

scholarly journals Multicenter, Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Small-Cell Lung Cancer (LUNGSTAR)

2017 ◽  
Vol 35 (14) ◽  
pp. 1506-1514 ◽  
Author(s):  
Michael J. Seckl ◽  
Christian H. Ottensmeier ◽  
Michael Cullen ◽  
Peter Schmid ◽  
Yenting Ngai ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Limited Disease ◽  
Extensive Disease ◽  
Double Blind ◽  
Patients With Cancer

Purpose Treating small-cell lung cancer (SCLC) remains a therapeutic challenge. Experimental studies show that statins exert additive effects with agents, such as cisplatin, to impair tumor growth, and observational studies suggest that statins combined with anticancer therapies delay relapse and prolong life in several cancer types. To our knowledge, we report the first large, randomized, placebo-controlled, double-blind trial of a statin with standard-of-care for patients with cancer, specifically SCLC. Patients and Methods Patients with confirmed SCLC (limited or extensive disease) and performance status 0 to 3 were randomly assigned to receive daily pravastatin 40 mg or placebo, combined with up to six cycles of etoposide plus cisplatin or carboplatin every 3 weeks, until disease progression or intolerable toxicity. Primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), response rate, and toxicity. Results Eight hundred forty-six patients from 91 United Kingdom hospitals were recruited. The median age of recruited patients was 64 years of age, 43% had limited disease, and 57% had extensive disease. There were 758 deaths and 787 PFS events. No benefit was found for pravastatin, either in all patients or in several subgroups. For pravastatin versus placebo, the 2-year OS rate was 13.2% (95% CI, 10.0 to 16.7) versus 14.1% (95% CI, 10.9 to 17.7), respectively, with a hazard ratio of 1.01 (95% CI, 0.88 to 1.16; P = .90. The median OS was 10.7 months v 10.6 months, respectively. The median PFS was 7.7 months v 7.3 months, respectively. The median OS (pravastatin v placebo) was 14.6 months in both groups for limited disease and 9.1 months versus 8.8 months, respectively, for extensive disease. Adverse events were similar between groups. Conclusion Pravastatin 40 mg combined with standard SCLC therapy, although safe, does not benefit patients. Our conclusions are the same as those found in all four much smaller, randomized, placebo-controlled trials specifically designed to evaluate statin therapy in patients with cancer.

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

Lung Cancer ◽  
2008 ◽  
Vol 61 (2) ◽  
pp. 220-226 ◽  
Author(s):  
Hoon-Gu Kim ◽  
Gyeong-Won Lee ◽  
Jung Hun Kang ◽  
Myung-Hee Kang ◽  
In-Gyu Hwang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Elderly Patients ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Small Cell ◽  
Small Cell Lung ◽  
Extensive Disease

Combination chemotherapy with carboplatin, etoposide, and vincristine as first-line treatment in small-cell lung cancer.

1992 ◽  
Vol 10 (5) ◽  
pp. 818-823 ◽  
Author(s):  
U Gatzemeier ◽  
D K Hossfeld ◽  
R Neuhauss ◽  
M Reck ◽  
W Achterrath ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Overall Response Rate ◽  
Response Rate ◽  
Small Cell ◽  
Small Cell Lung ◽  
Limited Disease ◽  
Extensive Disease ◽  
Overall Response

PURPOSE The antineoplastic activity of carboplatin and etoposide may be improved by the addition of vincristine (CEV) because of its low myelosuppressive potential and its activity in small-cell lung cancer (SCLC). A phase II study with CEV was carried out. PATIENTS AND METHODS One hundred twenty-one untreated patients with SCLC (63 with limited disease [LD], 58 with extensive disease [ED]) were treated with a combination of 300 mg/m2 intravenous (IV) on day 1, etoposide 140 mg/m2 IV daily on days 1 to 3, and vincristine 1.4 mg/m2 IV on days 1, 8, and 15 every 4 weeks. RESULTS A 90% rate overall response rate including 56% complete responses (CRs) was achieved in LD and an 83% overall response rate including 35% CRs was observed in ED. Median survival time was 13 months in limited disease and 9.5 months in extensive disease. The 24 and 36 months survival rates were 29% in LD and 9% in ED. Myelosuppression was the main form of toxicity. CONCLUSION The combination of CEV is a new active and well-tolerated regimen in the treatment of SCLC. Prospective randomized studies of CEV with conventional chemotherapy are warranted.

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