Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STEP trial.
BACKGROUND
Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence.


METHODS
Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥ 60% and unacceptable toxicity ≤ 25% were required to define a combination worthy of further studies.


RESULTS
Median age of 78 eligible patients was 74 years. GemVin produced a 36.7% objective response rate. GemEto and GemCis arms were found not sufficiently active. GemCar produced 16 responses (14 with area under the curve [AUC] 3.5 and 2 with AUC 4.0) in 26 patients (61.5%) and 6 cases of unacceptable toxicity (3 at each Car dose).


CONCLUSIONS
In elderly patients with extensive SCLC, GemVin, GemEto, and GemCis are not enough active and do not merit further studies. Gem plus Car might deserve further attention.
Medical Oncology, S. Giuseppe Moscati Hospital, Avellino, Italy. cgridelli@libero.it
Cesare
C
Gridelli
Ciro
C
Gallo
Alessandro
A
Morabito
Rosario Vincenzo
RV
Iaffaioli
Adolfo
A
Favaretto
Luciano
L
Isa
Santi
S
Barbera
Teresa
T
Gamucci
Anna
A
Ceribelli
Virginio
V
Filipazzi
Paolo
P
Maione
Antonio
A
Rossi
Emiddio
E
Barletta
Simona
S
Signoriello
Ermelinda
E
De Maio
Maria Carmela
MC
Piccirillo
Massimo
M
Di Maio
Gaetano
G
Rocco
Aldo
A
Vecchione
Francesco
F
Perrone
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D015999:Multivariate Analysis; D011379:Prognosis; D016016:Proportional Hazards Models; D011788:Quality of Life; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
D003841:Deoxycytidine; D014747:Vinblastine; D005047:Etoposide; D016190:Carboplatin; D002945:Cisplatin; D000077235:Vinorelbine; D000093542:Gemcitabine