s30
Oral Sessions/Patterns
@‘Practice
Results: The study was well balanced between the two treatment arms
in terms on age, sex, KPS and distribution of metastasis. The second line
chemotherapy used in patients of GV arm was carboplatin. No statistically significant difference was observed in overall survival (GV vs CGV) (median 275
vs 300 days; 1 year survival 26 vs 28%; p: 0.8) as well as in progression free
survival (median 150 vs 175 days; p: 0.4). The objective response rates were
40% for GV and 48% for CGV (p: 0.4). Pts in CGV had more haematological
and non-haematological toxicity including the only toxic death registered in this
study. Major toxicity grade 3-4 registered were (GV vs CGV; %); Anaemia (23
vs 38;~: 0.04) neutropenia (26 vs 48; p: 0.004); plaquetopenia (2 vs 14; p:O.Oi)
and neuropathy (4 vs 22; p: 0.007. Thrombocytosis was registered in 58% and
35% of pts treated with GV and CGV respectively which was associated with a
thrombotic episode in 14% of cases in both arms. Dose reduction and/or delay
of schedule of treatment were made in 60% and 73% of pts in GV and CGV
arm respectively.
Conclusions: At the moment to add cisplatin to the combination of GV has
not shown clear advantage in terms of efficacy despite causing more toxicity.
The results of this comparative study and others with similar characteristics
indicate that cisplatin could be omitted in the combinations of new and less
toxic agents.
0 92
El
PaclitaxeVcarboplatin (PC) vs
paclitaxel/carboplatin/gemcitabine
(PCG) in advanced
NSCLC: Preliminary results of an ongoing phase ll-lll
multicentric study
Adrian0 Paccaqnella, Adolf0 Favaretto, Francesco Oniga, Alessandra Bearz,
Maurizia Clerici, Faust0 Barbieri, Albert0 Riccardi, Maria Grazia Ghi,
Rita Biason, Salvatore Tumolo. on behalf of GSTPV/GOV, Venice, If&
Divisione Oncologia, Me&e, ltaly
Background: Based on Response Rate (RR) observed in our previous phase II
study, (Ann. Oncol. 11:1421-6, 2000), a phase ll-lll trial was initiated in 02/1998
to compare PC and PCG in advanced NSCLC.
Study Objectives: The primary aim of phase Ill was RR. Other end-points:
Time To Progression (TTP), Overall Survival (OS), Toxicity Profile and QoL.
Once sample size of 220 pts was reached, the protocol was emended to include 80 new pts in 8 months with a minimum follow-up of 6 months. Eligibility Criteria: Stage IIIB not suitable for Radiation therapy and stage IV; PS=O-2;
measurable disease; no prior chemotherapy. Treatment Arms: Arm A: Paclitaxel
200mg/m’ and Carboplatin AUC6 day 1 q21 days; Arm B: Paclitaxel 200mg/m2,
Carboplatin AUCG, day 1, and Gemcitabine 1000mg/mZ days I-8 q 21 days
(maximum 6 cycles). Stratification for Center and Stage.
Results: So far, 251 pts have been randomized. Median age was
59.3 (range 25-80); Sex M/F:76%/24%. Stage IIIB/IV: 33%/67%. PS O/1/2:
45.6%/49.0%/5.4%.
Histology: adeno/squamous/others:
45.4%/42.2%/12.4%.
Baseline characteristics are well balanced between the study arms. Response
Rate for PC and PCG was 19.5% vs 38.1%: P=O.O014; odd ratio adjusted for
prognostic factors: 2.75 (Cl.: 1.52-4.98):P=O.O008. RR for PC vs PCG according to Hystology: Adeno: 7.8% vs 33.3% (P=O.O012), Non-adeno: 28.4% vs
42.7% (P=O.O9). Adjusted odd ratio: 5.72 (Cl: 1.79 - 18.3): P=O.O03 and 1.94
(C.1: 0.9 - 4.O):P=O.O7. Median TTP for PC and PCG was 4.4 and 6.7 mo.
(P=O.O25); Cox method: HR 1.45 (Cl.: 1.08 - 1.96): P=O.O14. Median survival
for PC and PCG was 8.2 vs 10.7 mo; 1 year surv. 33.7% vs 45.4%, and 2 y
8.4% vs 17.9%. WHO G 3-4 Hematol. Tox for PC and PCG: neutropenia 37.4%
vs 58.8% (P=O.O04); thrombocytopenia
5.4% vs 34.5% (P<O.OOOl); anemia
6.25% vs 13.5% (P=O.O9). No differences in Non-Hematol. Tox were observed.
Toxic/early death: 4.9% vs 4.7%. Febrile neutropenia: 6,2% vs 8,l (P=NS):
Haemorrhage 2.5% vs 6.9% (P=NS).
Conclusions: In advanced NSCLC, PCG is significantly superior to PC in
RR and TTP. PCG induces a significant short-term increase in Hematol. Tox.
with no difference in febrile neutropenia, haemorrhage, toxic death and nonhemat. tox. compared to PC. Data on OS and QoL (EORTC QLQ-LC13) will be
presented after the completition of this ongoing study.
and Population-based
Outcomes
TUESDAY, 12 AUGUST 2003
Patterns of Practice and Population-based
Outcomes
El0 93
Radiotherapy
Patterns of Care Study in Lung Carcinoma
Benjamin Movsas’, Jennifer Moughan”, Ritsuko Komaki3, Hak Choy4,
Roger Byhardts, Corey Langer’, Melvyn Goldberg’, Mary GrahamG,
David Ettinger’, David Johnstones, Jean Owen’. ‘Fox Chase Cancer Center,
Philadelphia, USA; “American College of Radiology, Philadelphia, USA; 3 M.D.
Anderson Cancer Center, Houston, USA; 4 Vanderbilt University Cancer
Center, Nashville, USA; s Medical College of Wisconsin, Milwaukee, USA;
6 Phelps County Regional Medical Center, Rolla, USA; 7 The Johns Hopkins
Oncology Center, Baltimore, USA; 8 University of Rochester, Rochester, USA
Purpose: For the first time, a Lung Patterns of Care (PCS) study was conducted
to determine the national patterns of radiation (RT) practice in patients (pts)
treated for non-metastatic lung cancer in 1998-l 999.
Materials & Methods: A national survey of randomly selected RT institutions in the U.S. was conducted using two-stage cluster sampling, stratified by
practice type. Pts with AJCC 1997 non-metastatic lung ca (KPS >60), who received RT as definitive or adjuvant therapy, were randomly selected. To determine national estimates, sample size was weighted by the relative number institutions/per strata and the number of patient records reviewed per the number
of patients eligible (per institution). The weighted sample size of 42,335 patient
records from 58 institutions were reviewed by trained research associates. The
unweighted sample size (or number of patients) was 541.
Results: The histologies were small cell lung cancer (SCLC) in 14.5% vs
non-SCLC (NSCLC) in 85.5%. The median age was 67 yrs (range 29-92); 61%
were male and 38% were current smokers. While 98% had chest CTs for staging, bone scans and brain imaging were not obtained in 34% and 52% of clinical stage (CS) Ill NSCLC patients, respectively. Treatment strategies varied
significantly by histology and stage, p<O.OOOl. For example, in SCLC & CS
Ill NSCLC, chemo + RT was utilized significantly more than RT alone; in CS
I NSCLC, RT was the primary tx. CT-treatment planning was used in 49%. of
these, 52% reported utilizing “3-D conformal RT”. In CS Ill NSCLC patients,
CT-planning was utilized more in pts receiving chemo + RT (61%) vs RT alone
(30%), p=O.O47. Overall, 58% received systemic therapy. On both univariate
and multivariate analyses, factors correlating with increased use of chemotherapy included younger age, histology (SCLC > NSCLC), increasing CS, increasing KPS and lack of co-morbidities. of all chemo pts, 72% received it concurrently with RT. Surgery was performed in 23% of NSCLC pts. Only 3% of all pts
were treated on cooperative group trials or IRB-approved institutional trials.
(weighted
Treatment
groups>
RT Alone
RT + Chemo
RT + Surgery
RT + Surgery + Chemo
Total
SCLC
4.7*
(266; 6)
92.3
(5666; 61)
0.5’
(2% 1)
2.5”
(156;4)
100
(6138; 71)
Patient Groups’
Weighted %
sample size; unweighted
NSCLC-CS
(362: 42)
l&2*
(1098; 13)
9.9’
(597; 10)
11.8
(725; 5)
100
(6038; 70)
I
sample sue)
NSCLC-CS
2401
(1775; 30)
34.1
(2509; 17)
27.6
(2031; 24)
14.3’
(1053; 15)
100
(7366; 86)
II
NSCLC-CS
III
33.4
(7250; 92)
49.3
(10661; 139)
6.6
(1435: 22)
10.7
(2318; 41)
100
(21684; 294)
Most common tx for that pt grup (pcO.05); sequence of tx’s not specified. ‘Patient groups
exclude NSCLC patients with unknown clinical stage (weighted sample size = 1094 and
unweighted sample size = 16): ZUnrellable estimate (small unweighted sample size and/or
standard error >30% of estimate).
Conclusion: This study establishes the general patterns of care for lung ca
in RT facilities within the U.S. As supported by clinical trials, pts with limited
stage SCLC and CS ill NSCLC received chemo + RT > RT alone. Further
improvements in staging, smoking cessation and increased accrual to clinical
trials must be encouraged.
Supported by NCI Grant CA 65435.
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Used by leading Academics
Prof. Dr. İLHAN İLKILIÇ (MD PhD)
Istanbul University
Maxwell J Smith
University of Western Ontario
Philip C Hébert
University of Toronto
Sergio Rego
Fundação Oswaldo Cruz
