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Annals of Oncology
Cancer Centre (TBCC) in 1999, 2004 and 2009 (Glans-Look Lung Cancer Database).
All patients were restaged according to the new 7th Edition of the American Joint
Committee on Cancer TNM system for NSCLC staging. Survival was analyzed using
the Kaplan-Meier method and differences measured by a log rank test.
Results: 807 patients were included in the analysis (649 who were stage IV at
diagnosis, 158 who recurred with metastatic disease). Of these patients, 22.1%
received palliative systemic therapy (18.9% in 1999, 23.0% in 2004 and 23.1% in
2009). During this time, the proportion of patients who received 2 or more lines of
treatment almost doubled (6.9% in 1999, 9.0% in 2004 and 12.7% in 2009). In
addition, there was a trend towards increasing median overall survival (MOS) of
systemically treated patients over 1999-2009, from 10.8 months (95% CI: 8.4-13.3) in
1999 to 14.7 months (95%CI: 9.6-14.4) in 2009 (p = 0.2).
Conclusions: Our analysis suggests that there is an increasing proportion of metastatic
NSCLC patients being treated systemically at our centre, specifically, the proportion of
patients being treated with two or more lines of systemic therapy has increased over
the decade from 1999-2009. This study also suggests a trend toward an increased MOS
for systemically treated patients diagnosed in 2009 compared to those diagnosed in
1999. However, the vast majority of patients (>3/4) are still not being treated with
systemic therapy, despite the increase in available therapies now compared to a decade
ago. The reasons for this are not clear but may include poor ECOG performance
status, rapid decline, sub-optimal referral pathways and rural residence.
Disclosure: All authors have declared no conflicts of interest.
1351 DOES ELIGIBILITY FOR BEVACIZUMAB (BV) LEAD TO
SELECTION BIAS?
Y. Takagi 1 , A. Toriihara 2 , Y. Hosomi 1 , Y. Nakahara 1 , M. Akahane 1 , Y. Okuma 1 ,
M. Iguchi 1 , T. Okamura 1 , M. Shibuya 1
1 Department of Thoracic Oncology and Respiratory Medicine, Tokyo
Metropolitan Cancer and Infectious Diseases Center Komagome Hospital,
Tokyo, JAPAN, 2 Department of Radiology, Tokyo Medical and Dental University,
Tokyo, JAPAN
Background: Eligibility is often narrowed in clinical trials of targeted drugs
because of specific adverse effects. Modified eligibility criteria can affect endpoints
such as overall survival independently of the actual effect of an investigational
drug.
Methods: Patients with stage IIIB/IV, non-squamous non-small cell lung cancer
(NSCLC) who started chemotherapy from 2005 to 2009 were reviewed.
Bevacizumab (BV) was first used to treat lung cancer at our institution in 2010.
We divided patients into BV-eligible (A) and -ineligible (B) groups. To estimate
survival, Kaplan-Meier curves were calculated and compared between the groups
using the log-rank test. We also examined the prognostic impact of age, gender,
M factor, performance status (PS), use of platinum in first-line chemotherapy,
history of hemoptysis, major blood vessel invasion (MVI) by the tumor and
clinically significant cardiovascular disease upon overall survival using the Cox
proportional hazards model. A radiologist who was blinded to the clinical
outcomes evaluated MVI. All tests were two sided with a significance level of
0.05.
Results: Among 576 patients with lung cancer who undergone chemotherapy at
our department, 283 of them had stage IIIB/IV non-squamous NSCLC. After
excluding 15 patients with indications for combined chemoradiotherapy and 22
with PS 3/4, the eligibility of 246 patients for BV was finally evaluated.
Eighty-nine patients were considered ineligible for BV (cohort B), based on one or
more of a history of hemoptysis (N = 32), MVI (N = 64) and cardiovascular
disease (N = 13). Eligibility could not be determined in ten patients and the
remaining 147 patients were classified into cohort A. Overall survival was
significantly better in cohort A (median, 14.9 months) than in cohort B (median,
8.6 months; hazard ratio, 0.55; 95%CI, 0.42-0.74; P < .0001). Multivariate analysis
indicated that gender, PS, a history of hemoptysis and MVI are significant
prognostic factors.
Conclusion: Eligibility for BV itself is a powerful prognostic factor for patients with
non-squamous NSCLC.
Disclosure: All authors have declared no conflicts of interest.
1352 CLINICAL PROFILE AND PATTERNS OF PROGRESSION (PD)
OF PATIENTS (PTS) WITH ADVANCED NON-SQUAMOUS
NON-SMALL CELL LUNG CANCER (NSNSCLC) TREATED
WITH FIRST LINE BEVACIZUMAB (B): AVVA STUDY
J. De Castro 1 , J.M. Garcia-Bueno 2 , M. Domine 3 , S. Saura 4 , R. Garcia-Gomez 5 ,
M. Sereno 6 , O. Juan 7 , E. Pujol 8 , B. Rubio 9 , M. Cobo 10
1 Medical Oncology, Hospital Universitario La Paz, Madrid, SPAIN, 2 Oncology
Deparment, Hospital General de Albacete, Albacete, SPAIN, 3 Oncology,
Fundacion Jeminez DiazClin Nstra Senora de la Concepcion, Madrid, SPAIN,
4 Medical Oncology, Hospital Universitario Dr. Negrin, Las Palmas de Gran
Canaria, SPAIN, 5 Medical Oncology, Hospital General Universitario Gregorio
Marañon, Madrid, SPAIN, 6 Medical Oncology, Hospital Infanta Sofia, Madrid,
SPAIN, 7 Medical Oncology, Hospital Arnau de Vilanova, Valencia, SPAIN,
8 Medical Oncology, Hospital Santa Barbara, Soria, SPAIN, 9 Medical Oncology,
Centro Integral Oncológico Clara Campal, Madrid, SPAIN, 10 Medical Oncology,
Hospital Regional Universitario Carlos Haya, Malaga, SPAIN
Background: B in combination with platinum doublets prolongs survival and delays
PD in chemo-naïve pts with advanced nsNSCLC and its safety profile has been
widely described in clinical trials. In this study we aim to evaluate the behavior,
clinical profile and patterns of PD of real-life nsNSCLC pts treated with B in 44
Spanish institutions.
Methods: AVVA is a multicenter, epidemiological study to define the clinical profile
(gender, age, PS, histology, stage, comorbidities, tumor load, Tx, response and
tolerability) and describe the patterns of PD. Pts diagnosed with advanced nsNSCLC
and evidence of PD after treatment (Tx) with standard chemotherapy (CT) plus B
up to 6 cycles followed by maintenance B were included.
Results: Data of 158 pts are presented. Clinical profile was: median age 58 years
(range 34-79); male 65%; stage IV 91%; adenocarcinoma 77%; ECOG PS 0/1/ ≥ 2
(%): 35/56/9; never/current/former smokers (%): 23/40/37. 64% of pts presented
relevant concomitant disease at baseline (27% cardiovascular disease, 24% pulmonary
disease). Tx received: B plus carboplatin-doublet/cisplatin-doublet/other (%) 70/25/5.
Median no. of cycles for CT/B: 6/9. Patterns of PD: 44% presented high tumor load
(tumor diameter ≥55mm and ≥5 lesions); 97% of pts presented intra-thoracic
disease, 53% presented extra-thoracic disease and 13% only pulmonary disease. High
tumor load was associated with extra-thoracic disease (p < 0.05). ORR was 53% (95%
CI: 45-61) and disease control rate was 85%. Best response was achieved after a
median of 4 cycles (range 1-16). ECOG 0/1 at PD (%): 15/50. Median PFS was 7.7
months (95% CI: 7.3-8.1). No differences were found in ORR or PFS according to
tumor load and intra/extra-thoracic disease. Grade 3/4 toxicities were: venous
thrombosis (3.2%/0), proteinuria (0.6%/0), hemoptysis (0.6%/0), pulmonary
embolism (0/0.6%) and mucositis (0.6%/0).
Conclusions: B was effective in this real-life patients’ population, irrespective of
tumor load and location of the disease. These results confirm the well-established
safety profile and the efficacy of B as frontline Tx in nsNSCLC.
Disclosure: All authors have declared no conflicts of interest.
1353 PHASE II TRIAL OF BEVACIZUMAB PLUS DOCETAXEL IN
PATIENTS WITH PREVIOUSLY TREATED NON-SQUAMOUS
NON-SMALL CELL LUNG CANCER
F. Ohyanagi, K. Kudo, N. Yanagitani, A. Horiike, T. Horai, M. Nishio
Thoracic Oncology Center, Cancer Institute Hospital, Japanese Foundation for
Cancer Research, Tokyo, JAPAN
Background: The additional effects of bevacizumab (B) as a first line chemotherapy
for non-squamous (Nsq) non-small cell lung cancer (NSCLC) have been established.
However, its efficacy as a second line or higher chemotherapeutic agent is not
sufficiently investigated. Docetaxel (D) is a standard second line therapy for NSCLC,
and the synergistic effects of a combination of D and B (D + B) have been
demonstrated in preclinical models. Therefore, this phase II study evaluated the
efficacy and safety of D + B in patients with previously treated Nsq NSCLC.
Methods: Patients with histologically or cytologically confirmed Nsq NSCLC (20–74
years) with an Eastern Cooperative Oncology Group performance status (PS) of 0-2
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds409 | ix441