Lung Cancer 35 (2002) 73–79
A phase II study of gemcitabine plus cisplatin in patients with
advanced non-small cell lung cancer: clinical outcomes and quality
of life
Jacek Jassem
a,
*, Maciej Krzakowski
b
, Kazimierz Roszkowski
c
, Rodryg Ramlau
d
,
Jan Marek Slomin ´ ski
a
, Aleksandra Szcze ˛sna
e
, Kazimierz Krawczyk
f
,
Barbara Moz ejko-Pastewka
g
, Joanna Lis
g
, Krzysztof Miracki
g
a
Medical Uniersity of Gdan ´sk, 7 De ˛binki Street, 80 -211 Gdan ´sk, Poland
b
Marie Curie -Sklodowska Memorial Institute of Oncology, Warsaw, Poland
c
Institute of Tuberculosis and Lung Diseases, Warsaw, Poland
d
Hospital of Lung Diseases and Tuberculosis, Poznan ´ , Poland
e
Hospital of Lung Diseases and Tuberculosis, Otwock, Poland
f
John Paul II Hospital, Cracow, Poland
g
Eli Lilly, Warsaw, Poland
Received 21 March 2001; received in revised form 4 July 2001; accepted 10 July 2001
Abstract
The aim of the present phase II study was to assess the activity and safety of gemcitabine–cisplatin combination in advanced
NSCLC, and to evaluate the impact of this regimen in terms of symptom benefit and quality of life (QOL). Eighty patients with
pathologically confirmed advanced (stage IIIB and IV) NSCLC were enrolled into this study. Gemcitabine was administered on
days 1, 8 and 15 at a dose of 1000 mg/m
2
, and cisplatin was given on day 2 at a dose of 100 mg/m
2
. The cycles were repeated
every 4 weeks. The impact of treatment on QOL and on tumor-related symptoms was evaluated with the validated EORTC forms
(QLQ-C30 and LC-13). The regimen was relatively well tolerated. Myelosuppresion was the principal toxicity. Grade 3/4
neutropenia, thrombocytopenia and anemia occurred in 58, 65 and 30% of patients respectively. In 143 cycles (35%) the
administration of gemcitabine on day 15 was omitted due to myelosuppresion. Non-hematological toxicities were generally mild.
Among the 76 patients available for response evaluation, there were 5 complete responses (7%) and 26 partial responses (34%);
an overall response rate of 41%. The median duration of response was 8.0 months. The median survival for all 80 patients was
11.0 months and the actuarial 1-year survival probability 45%. During therapy global QOL improved in 22% of patients and
particular functional domains increased in 19 – 37% of patients. Dyspnea was released in 36% of patients, fatigue in 45%, chest
pain in 38%, shoulder pain in 27%, cough in 44%, and hemoptysis in 75%. The mean intensity scores of the last three symptoms
decreased significantly with therapy. Our study confirmed relatively high efficacy of the gemcitabine – cisplatin combination in
patients with advanced NSCLC. Of particular importance was that treatment with gemcitabine – cisplatin combination in a large
proportion of patients was also associated with remarkable symptomatic release and with improvement of QOL. However, the
high frequency of myelotoxicity-related gemcitabine omissions on day 15 of the cycle indicates that modification of the schedule
should be considered in standard care. © 2002 Elsevier Science Ireland Ltd. All rights reserved.
Keywords: Advanced non-small cell lung cancer; Chemotherapy; Gemcitabine; Cisplatin; Quality of life
www.elsevier.com/locate/lungcan
Further investigators: J. Zych, B. Szczepek (Institute of Tuberculosis and Lung Diseases, Warsaw), T. Denisso, W. Lasota, A. Janowicz, D.
Kowalski (Institute of Oncology, Warsaw), A. Szadkowska, G. Czyz ewicz, B. Sikora (Cracow), E. Jassem, B. Cynowska, H. Wolf, A. Zielin ´ ski
A. Badzio, M. Drozd-Lula, R. Dziadziuszko (Gdan ´ sk), M. Sieciechowicz (Poznan ´), A. S
´
wia ˛tecka-Baczyn ´ ska, A. Guzowska (Otwock).
* Corresponding author. Tel./fax: +48-58-3492270.
E-mail address: jjassem@amg.gda.pl (J. Jassem).
0169-5002/02/$ - see front matter © 2002 Elsevier Science Ireland Ltd. All rights reserved.
PII:S0169-5002(01)00286-0