Abstract
Background: To explore a new schedule of gemcitabine-cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients entered the study and 88 (28 with locally advanced and 60 with disseminated NSCLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m2 was given on days 1-8 plus cisplatin 100 mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42% (95% confidence interval (CI): 27.8%-56.7%) and 47% (95% CI: 31.6%-61.5%), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 months (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3-4 toxicities in arm A vs. arm B included: thrombocytopenia (23% vs. 17% of courses), leukopenia (15% vs. 4% of courses), anemia (7% vs. 6% of courses), and nausea-vomiting (20% vs. 7% of patients). Grade 1-2 nephrotoxicity occurred in 20% of patients in arm A and in 7% of patients in arm B, with one grade 4 episode in arm A. Six patients discontinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasible and active, with a milder toxicity in the arm with the lower cisplatin dose.
| Original language | English |
|---|---|
| Pages (from-to) | 1295-1300 |
| Number of pages | 6 |
| Journal | Annals of Oncology |
| Volume | 11 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 2000 |
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Keywords
- Advanced NSCLC
- Cisplatin dose level
- Gemcitabine-cisplatin combination
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels : A phase II randomized trial. / Rinaldi, M.; Crinò, L.; Scagliotti, G. V.; Mosconi, A. M.; De Marinis, F.; Gridelli, C.; Selvaggi, G.; Della Giulia, M.; Darwish, S.; Porrozzi, S.; Novello, S.; Cipri, A.; Bartolucci, R.; Calandri, C.; Tonato, M.
In: Annals of Oncology, Vol. 11, No. 10, 2000, p. 1295-1300.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels
T2 - A phase II randomized trial
AU - Rinaldi, M.
AU - Crinò, L.
AU - Scagliotti, G. V.
AU - Mosconi, A. M.
AU - De Marinis, F.
AU - Gridelli, C.
AU - Selvaggi, G.
AU - Della Giulia, M.
AU - Darwish, S.
AU - Porrozzi, S.
AU - Novello, S.
AU - Cipri, A.
AU - Bartolucci, R.
AU - Calandri, C.
AU - Tonato, M.
PY - 2000
Y1 - 2000
N2 - Background: To explore a new schedule of gemcitabine-cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients entered the study and 88 (28 with locally advanced and 60 with disseminated NSCLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m2 was given on days 1-8 plus cisplatin 100 mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42% (95% confidence interval (CI): 27.8%-56.7%) and 47% (95% CI: 31.6%-61.5%), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 months (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3-4 toxicities in arm A vs. arm B included: thrombocytopenia (23% vs. 17% of courses), leukopenia (15% vs. 4% of courses), anemia (7% vs. 6% of courses), and nausea-vomiting (20% vs. 7% of patients). Grade 1-2 nephrotoxicity occurred in 20% of patients in arm A and in 7% of patients in arm B, with one grade 4 episode in arm A. Six patients discontinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasible and active, with a milder toxicity in the arm with the lower cisplatin dose.
AB - Background: To explore a new schedule of gemcitabine-cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients entered the study and 88 (28 with locally advanced and 60 with disseminated NSCLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m2 was given on days 1-8 plus cisplatin 100 mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42% (95% confidence interval (CI): 27.8%-56.7%) and 47% (95% CI: 31.6%-61.5%), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 months (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3-4 toxicities in arm A vs. arm B included: thrombocytopenia (23% vs. 17% of courses), leukopenia (15% vs. 4% of courses), anemia (7% vs. 6% of courses), and nausea-vomiting (20% vs. 7% of patients). Grade 1-2 nephrotoxicity occurred in 20% of patients in arm A and in 7% of patients in arm B, with one grade 4 episode in arm A. Six patients discontinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasible and active, with a milder toxicity in the arm with the lower cisplatin dose.
KW - Advanced NSCLC
KW - Cisplatin dose level
KW - Gemcitabine-cisplatin combination
UR - http://www.scopus.com/inward/record.url?scp=0033758715&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0033758715&partnerID=8YFLogxK
U2 - 10.1023/A:1008334610955
DO - 10.1023/A:1008334610955
M3 - Article
C2 - 11106119
AN - SCOPUS:0033758715
VL - 11
SP - 1295
EP - 1300
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 10
ER -