TY - JOUR
T1 - Phase II trial of acivicin versus etoposide-cisplatin in non-small cell lung cancer
T2 - An Eastern Cooperative Oncology Group study
AU - Bonomi, P.
AU - Finkelstein, D.
AU - Chang, A.
N1 - Funding Information:
Treatment-related deaths in small cell lung cancer trials: Can patients at risk be identified? Stephens RJ, Girling DJ, Machin D. M. Res. Council Cancer Trials Office, 5 Shafresbwy Road. Cambridge CB2 2BW. Lung Cancer (Ireland) 1994;11:259-74. Objectives: This paper investigates the problem of treatment-related deaths in small cell lung cancer (SCLC). Design: To observe and define increased hazard levels, and to identify factors relating to these excess deaths. Setting: The United Kingdom. Subjects: A total of 2 196 patients entered into the series of six randomised clinical trials in SCLC conducted by the Medical Research Council (MRC) Lung Cancer Working Party (LCWP). Results: In this large series of patients an increased risk of death in the second week after commencing the first cycle of chemotherapy was observed, suggesting that of the 10% of patients who died within 3 weeks of starting chemotherapy, half may have been treatment-related. Much less additional risk was associated with subsequent cycles of chemotherapy, and no additional risk with either initial surgery or radiotherapy. Radford et al. [Eur J Cancer 1993; 29A: 81-861 suggested that the risk factors for death from sepsis were a Kamofsky Performance (KP) score of ~50 (translated as a WHO performance grade (F’S) ;i 3), age > 50 years and three or more drugs in the chemotherapy regimen utilised. Starting with this model we found that our data suggest it can be refined by omitting age and including a white blood cell count > 10 OOO/mm’ (this variable was not tested by Radford), and changing the other categories to WHO PS 2 2 (Kp 5 70), and four or more drugs. Within our data this revised model identified a high risk group of patients with an excess death rate of more than 15% in the second week after starting chemotherapy. Radford et als’ suggestion that high risk patients be given haIf doses of drugs at the first cycle shouldbe tested in a random&xi clinical trial.
PY - 1994
Y1 - 1994
N2 - Identification of effective new chemotherapeutic agents is a major objective of clinical research efforts in patients who have metastatic non- small cell lung cancer (NSCLC). Canadian investigators observed responses in NSCLC when acivicin was given as a daily IV bolus for 5 consecutive days. Based on these results the Eastern Cooperative Oncology Group tested acivicin as a continuous infusion in patients with advanced NSCLC. A total of 82 patients were entered on a Phase II trial in which patients have randomized either to acivicin 60 mg/m2 given as a continuous intravenous infusion over 72 hours repeated every 28 days or to the reference regimen which consisted of cisplatin 60 mg/m2 intravenously on day 1 and etoposide 120 mg/m2 daily on days 1, 2, and 3 repeated every 28 days. Five partial remissions (11%) were observed in 42 patients treated with etoposide-cisplatin, and no responses were observed in 40 patients treated with acivicin. Median survival durations for etoposide cisplatin and for acivicin were 29.7 and 21.1 weeks, respectively. Based on these results, acivicin appears to be inactive in NSCLC.
AB - Identification of effective new chemotherapeutic agents is a major objective of clinical research efforts in patients who have metastatic non- small cell lung cancer (NSCLC). Canadian investigators observed responses in NSCLC when acivicin was given as a daily IV bolus for 5 consecutive days. Based on these results the Eastern Cooperative Oncology Group tested acivicin as a continuous infusion in patients with advanced NSCLC. A total of 82 patients were entered on a Phase II trial in which patients have randomized either to acivicin 60 mg/m2 given as a continuous intravenous infusion over 72 hours repeated every 28 days or to the reference regimen which consisted of cisplatin 60 mg/m2 intravenously on day 1 and etoposide 120 mg/m2 daily on days 1, 2, and 3 repeated every 28 days. Five partial remissions (11%) were observed in 42 patients treated with etoposide-cisplatin, and no responses were observed in 40 patients treated with acivicin. Median survival durations for etoposide cisplatin and for acivicin were 29.7 and 21.1 weeks, respectively. Based on these results, acivicin appears to be inactive in NSCLC.
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U2 - 10.1097/00000421-199406000-00006
DO - 10.1097/00000421-199406000-00006
M3 - Article
C2 - 8192104
AN - SCOPUS:0028285177
SN - 0277-3732
VL - 17
SP - 215
EP - 217
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 3
ER -