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MO08 - NSCLC - Early Stage (ID 117)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:K. Nakagawa, J. Douillard
- Coordinates: 10/28/2013, 16:15 - 17:45, Bayside Gallery B, Level 1
MO08.02 - Adjuvant pazopanib or placebo in resected stage I NSCLC patients: results of the NSCLC adjuvant randomized phase II trial (IFCT-0703) from the French collaborative Intergroup (ID 2274)
16:15 - 17:45 | Author(s): B. Milleron
Although UFT is approved in eastern countries, most guidelines do not recommend any adjuvant treatment in resected Stage I NSCLC. Pazopanib (P) is a potent, orally active multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, platelet derived growth factor (PDGFR) type-α and –β, approved in metastatic renal cell carcinoma and sarcoma. Neoadjuvant P demonstrated single-agent activity in patients with early stage NSCLC. We report the feasibility and tolerance of adjuvant P in stage I NSCLC.
In this double-blind randomized multicenter phase II/III trial, completely resected patients (pts) with stage I NSCLC (7[th] TNM edition) were randomized to receive either placebo or P 800 mg/d during 6 months. The Fleming’s two stage phase II primary endpoint was compliance (i.e. % of pts able to receive at least 3 months of P, whatever the dose). After 64 pts included (interim analysis), IDMC recommended to start with P 400 mg/d because of initial insufficient compliance. A one-step Fleming design was used with the new dose. Phase II design was not comparative.
143 pts were randomized in 29 centers between March 2009 and August 2012, 71 and 72 in the placebo and P arms respectively. Most pts were male (61%) and smokers (91%), median age was 60. Pathological stage was IA in 111 pts (78%) and 16% were squamous cell carcinomas. Compliance for P800 was adequate in 38% (95% confidence interval [21-56]) vs. 87% [71-96] in placebo; for P400 in 69% [50-84] (p=0.01, compared to P800) vs. 93% [77-99] in placebo. Dose modifications were seen in 44% and 34% of P800 and P400 groups. The proportion of patient with at least one grade 3/4 toxicity was 53% [35-71] in P800 (13% [4-29] for placebo) and 38% [21-56] in P400 (27% [12-46] for placebo). No toxic deaths were observed. Only 2 pts has grade 4 toxicities in P800 (fatigue in P arm, GGT in the placebo arm). Most common toxicities G3 in P800 were diarrhea (9%), hypertension (9%), and increased transaminases (16% vs. 0% in P400); in P400 gastro-intestinal disorders (16%, 6% diarrhea) and hypertension (6%).
IFCT-0703 is the first feasibility study demonstrating that full dose of P is safe but not feasible in the adjuvant setting in NSCLC. Compliance and tolerance with reduced dose appeared acceptable for adjuvant settings.
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P3.24 - Poster Session 3 - Supportive Care (ID 160)
- Event: WCLC 2013
- Type: Poster Session
- Track: Supportive Care
- Presentations: 1
- Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
P3.24-038 - Perception of lung cancer among the general population and comparison with other cancers. (ID 2692)
09:30 - 16:30 | Author(s): B. Milleron
After decades of very slow progresses, lung cancer management rapidly evolved in the past few years. One could anticipate a possible leap in perception of the disease between patients and physicians.
We conducted a prospective nationwide observational survey of 2200 healthy subjects selected within a representative permanent polling database according to the relevant national and European laws. We collected data in relation to aetiology, epidemiology, diagnostic, therapy and prognostic by using a specific questionnaire as well as perception of lung cancer by using a lexical approach. Among them, 1629 returned the questionnaire and 1469 were eligible for a full analysis.
We observed that the population has an average high level of information regarding epidemiological changes of lung cancer (“same incidence” for 40%, “higher incidence” for 47%, “increase in women” for 75%), and main risk factors (tobacco 93%, occupational 81% and environmental exposure 56%). Two thirds (67%) are aware of the danger of passive smoking. Only 22% of the whole population believed to be at risk of lung cancer. Differences were seen according to smoking habits as 62% of current smokers, 21% of former smokers and 6% of never-smokers believed to be at risk (p < 0.05) and according to the age, as 15% of responders above 65 years old thought to be at risk in comparison of 26% of responders below 34 (p < 0.05). The population overestimated the overall survival of lung cancer (32%) and underestimated the potential cure of early stage disease (52%). The participants clearly identified lung cancer as a severe disease (82%) with a worse prognostic than other cancers (colorectal, breast, prostate, p < 0.05). Most of the population was aware of the main treatments of lung cancer (surgery, chemotherapy and radiotherapy) but only 45% cited targeted therapy. By using lexical tests we observed that corpus can be split in two main lexical repertoires: a) the major repertoire in which the significant units have encoded lung cancer identified as a tobacco-induced, life-threatening disease, imposing heavy treatment and b) the minor repertoire in which significant units belonged to the representation of lung cancer as an environmental-induced disease. In comparison with breast cancer, lung cancer is characterized by a greater feeling of guilt and a more frequent association with the way of life.
We deciphered some aspects of lung cancer perception in the general population and anticipated that it may improve psychological adjustment in patient-doctor communication, fill in the knowledge gap of the perception of the disease and eventually help in lung cancer management.