| Bimodality lung oncology team (BLOT) trial of induction paclitaxel/carboplatin in early stage non-small cell lung cancer (NSCLC): Long term followup of a phase II trial.
Category:
Non-Small-Cell Lung Cancer
Authors:
K. Pisters, R. Ginsberg, D. Giroux, M. Kris, J. B. Putnam, J. R.
Roberts, D. Johnson, J. Crowley, P. A. Bunn, for the Bimodality
Lung Oncology Team; M. D. Anderson Cancer Center, Houston, TX; University
of Toronto, Toronto, Canada; Cancer Research and Biostatistics,
Seattle, WA; Memorial-Sloan Kettering Cancer Center, New York, NY;
M. D. Anderson Cancer Center, Houston, TX; Vanderbilt University,
Nashville, TN; University of Colorado, Denver, CO
Abstract:We previously
reported feasibility of the first cohort in a phase II trial of
induction paclitaxel/carboplatin chemotherapy in clinical stage
IB-IIIA NSCLC (N0/N1) patients (J Thorac Cardiovasc Surg 2000;119:429-39).
Median time from study entry is now 4.8 years (range 3.5-5.5). Patients
received paclitaxel (225 mg/m2/3 hours) and carboplatin
(AUC=6), intravenously, every 21 days before and after surgery (number
of cycles: cohort I:2 pre, 3 post; cohort II: 3 pre, 2 post). Patient
characteristics did not differ between cohorts. The number of patients
(N), major radiographic response rate (RR) and 95% confidence intervals
to induction paclitaxel/carboplatin (I-PC), patients progressing
during I-PC (PD), patients completing I-PC (C:I-PC), % patients
with any grade 4 toxicity during I-PC (G4), operative mortality
(Op Mort), and 1-, 3- and 5-year survival rates (YS) are shown.
Survival rates are superior to historical controls. There were no
major differences between the cohorts in any of these parameters.
To date 58 patients (43%) have relapsed, sites as follows: 10 (17%)
local, 12 (21%) brain only, 25 (43%) other distant, and 11 (19%)
local and distant. These sites of relapse are similar to historical
series. We conclude that 2 or 3 cycles of induction paclitaxel/carboplatin
chemotherapy is feasible, safe, does not compromise surgery and
leads to favorable survival in early stage NSCLC. A randomized intergroup
study (SWOG 9900) is underway to confirm these results. Supported
in part by a grant from Bristol-Myers Squibb.
| Cohort |
N |
RR |
PD |
C:I-PC
|
G4 |
Op
Mort |
1 YS |
3 YS |
5 YS |
2 preop
cycles |
94 |
56%
(46-67%) |
4% |
96% |
21% |
2% |
87% |
63% |
46% |
3 preop
cycles |
40 |
40%
(25-57%) |
8% |
90% |
28% |
0% |
76% |
48% |
NR |
| Total |
134 |
51%
|
5% |
94% |
23% |
1% |
85% |
61% |
42% |
|
