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E. Holmberg
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ORAL 19 - Radiation for Localized Lung Cancer (ID 126)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:D. De Ruysscher, M. Hiraoka
- Coordinates: 9/08/2015, 10:45 - 12:15, 102+104+106
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ORAL19.01 - The SPACE Study: A Randomized Phase II Trial Comparing SBRT and 3DCRT in Stage I NSCLC Patients; Final Analysis including HRQL (ID 923)
10:45 - 10:56 | Author(s): E. Holmberg
- Abstract
- Presentation
Background:
Stereotactic body radiotherapy (SBRT) for NSCLC patients with T1-T2 tumors has been intensively studied the last decades and is widely used due to excellent results in terms of local control and survival in combination with the convenient and fast treatment procedure. This radiation technique has however never been compared to standard radiotherapy in a randomized manner, and consequently the Swedish lung cancer study group launched the SPACE study in 2007 (Stereotactic Precision And Conventional radiotherapy Evaluation).
Methods:
Patients with stage I medically inoperable histologically confirmed NSCLC or PET-positive tumors with progression (non-centrally located with a maximum size < 5 cm) were randomized in 9 Scandinavian centers to receive SBRT to 66 Gy in 3 fractions in one week or conventionally fractionated 3DCRT to 70 Gy in 7 weeks. Patients were followed with regard to treatment efficacy, toxicity and HRQL.
Results:
Between January 2007 and July 2011 102 patients were randomized (49 SBRT, 53 3DCRT). Mean age 74 (57-86), 60% women and the vast majority (92%) had COPD or cardiovascular comorbidity. The mean FEV1 and mean CO-diffusion capacity were 1.4 L and 55% respectively. Seventy-four percent had a histopathologic diagnose where the majority were adenocarcinomas and 65% had T1 tumors and 35% T2. The two treatment groups differed somewhat in terms of tumor size and gender where the SBRT arm included more patients with T2 tumors and of male gender. The median follow-up is 37 months with a 1- 2- and 3 year PFS of: SBRT: 89%, 70%, 62% and 3DCRT: 88%, 66% 58% with no difference between the groups and no difference regarding OS. At the end of study 72% were without progression among the SBRT patients compared to 59% in the conventional arm. Toxicity was generally low, grade ≥ 3 of any toxicity was observed in 19% in SBRT patients and 15% in the 3DCRT group with no grade 5 toxicities. Pneumonitis of any grade was observed in 19% (SBRT) and 36% (3DCRT), and any grade esophagitis in 8% and 30% respectively. HRQL was evaluated with the EORTC QLQ 30 and LC14 module and patients treated with 3DCRT experienced worse dyspnea, cough and chest pain compared to the SBRT patients.
Conclusion:
NSCLC stage I patients treated with SBRT had the same PFS and OS as the conventionally treated patients despite an imbalance of prognostic factors with regards to more T2 tumors and males in the SBRT group. There was a tendency to improved disease control rate in the SBRT patients and in addition they experienced higher QoL values regarding dyspnea, cough and chest pain. SBRT should be considered standard therapy for this patient group.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-061 - COX-2 Expression Does Not Predict Outcome of Celecoxib in Addition to Standard Chemotherapy in Advanced Non-Small Cell Lung Cancer (ID 2100)
09:30 - 09:30 | Author(s): E. Holmberg
- Abstract
Background:
Increased expression of cyclooxygenase-2 (COX-2) is common in non-small cell lung cancer (NSCLC), and is therefore a potential target for treatment. However, phase III trials have failed to demonstrate beneficial survival effects of adding COX-2 inhibitors to standard chemotherapy. We investigated whether COX-2 expression in tumor and stromal cells had any predictive impact on the effects of celecoxib, a selective COX-2 inhibitor.
Methods:
In a previously published multicenter phase III trial, 316 patients with NSCLC stage IIIB or IV and WHO performance status 0-2 were randomized to receive celecoxib 400 mg b.i.d. or placebo up to one year in addition to a two-drug platinum-based chemotherapy regimen. In a subset of 122 patients, archive tumor tissue was available for further analyses. Immune stainings for COX-2 expression were undertaken. Intensity and extent of positively stained cells in tumor and stroma cells were scored on a 0 to 3 scale, and the product of these scores was used as a co-variable in the predictive analysis.
Results:
An updated analysis of all 316 patients included in the original trial, and of the 122 patients with available tumor tissue showed no survival differences between the celecoxib or placebo arms (HR 0.99; 95% CI 0.79-1.24 and HR 0.89; 95% CI 0.62-1.28, respectively). Similarly, in patients with high COX-2 expression in tumor cells (n=71) or stroma cells (n=55), survival did not differ significantly between patients who received celecoxib or placebo (HR 0.96; 95% CI 0.60-1.54 and HR 0.66; 95% CI 0.38-1.16). The p-value for interaction effect between COX-2 score in tumor or stroma cells and celecoxib effect on survival was 0.48 and 0.25, respectively.
Conclusion:
In this subgroup analysis of patients with advanced NSCLC treated in a randomized trial, we could not detect any significant interaction between COX-2 expression in tumor or stroma cells and outcome of celecoxib treatment in addition to standard chemotherapy.
