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Óscar Juan-Vidal
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-70 - Efficacy and Safety of Second- or Third-Line Nab-Paclitaxel + Durvalumab in Patients with Advanced NSCLC (ABOUND.2L+) (ID 13042)
16:45 - 18:00 | Author(s): Óscar Juan-Vidal
- Abstract
Background
Cytotoxic chemotherapy may enhance the effect of immune checkpoint blockers (ICBs) through interaction with the immune system (immunostimulation) and cancer cells (increased antigenicity). The phase II ABOUND.2L+ trial investigated second-/third-line nab-paclitaxel monotherapy, nab-paclitaxel + CC-486, or nab-paclitaxel + durvalumab in patients with previously treated advanced-stage NSCLC. This report presents an updated analysis of the efficacy and safety from the nab-paclitaxel + durvalumab treatment arm.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients ≥ 18 years with advanced NSCLC and no more than 1 prior line of platinum-containing chemotherapy (ICBs in prior line, first/second, allowed) were included. Patients were treated with nab-paclitaxel on days 1 and 8 + durvalumab 1125 mg on day 15 of a 21-day cycle until unacceptable toxicity or progressive disease as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or immune-related RECIST v1.1. The primary endpoint was progression-free survival (PFS). Key secondary endpoints included overall response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
4c3880bb027f159e801041b1021e88e8 Result
A total of 79 patients were assigned to nab-paclitaxel + durvalumab. The median age of patients in that arm was 63.0 years; 68.4% were male, 97.5% were white, 77.2% had ECOG performance status 1, and 69.6% had nonsquamous histology; 8 patients received prior ICBs. Median and 1-year PFS were 4.5 months (95% CI: 3.45-5.88) and 25.7% (95% CI 16.3-36.2); median PFS in those with and without prior ICB treatment was NE (95% CI 1.38-NE) and 4.4 months (95% CI 2.96-5.68) and in those with squamous and nonsquamous histology was 6.0 months (95% CI 2.99-7.75) and 4.2 months (95% CI 2.86-5.75). The ORR was 27.8%, and DCR was 70.9%. Median OS was 10.1 months (95% CI: 7.75-NE). Median percentage of per protocol dose was 87.5% for nab-paclitaxel and 82.9% for durvalumab. All patients had at least 1 treatment-emergent adverse event (TEAE), and 67.9% had at least 1 grade 3 or 4 TEAE. Common TEAEs of special interest (all grades) included peripheral neuropathy (grouped term; 37.2%), diarrhea (34.6%), anemia (30.8%), dyspnea (25.6%), nausea (24.4%), cough (24.4%), pyrexia (19.2%), and neutropenia (17.9%). TEAEs leading to dose interruption/reduction (nab-paclitaxel and/or durvalumab) were reported in 73.1% of patients, and those leading to discontinuation in 11.5%.
8eea62084ca7e541d918e823422bd82e Conclusion
nab-Paclitaxel + durvalumab demonstrated promising antitumor activity and manageable toxicity in second- or third-line treatment of patients with advanced NSCLC. NCT02250326.
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P1.01-93 - Quality of Life in Patients with Advanced NSCLC Treated in Second- or Third-Line with Nab-Paclitaxel + Durvalumab: ABOUND.2L+ (ID 12993)
16:45 - 18:00 | Author(s): Óscar Juan-Vidal
- Abstract
Background
Quality of life (QoL) can be adversely affected in patients with advanced NSCLC, particularly those receiving second- or third-line treatment. In these patients, checkpoint inhibitors are a recommended treatment option. Through multiple mechanisms, including the release of tumor antigens via tumor cell lysis, chemotherapy can augment immunotherapeutic effects, which is the rationale for combining chemotherapy with immunotherapy agents. The phase II ABOUND.2L+ trial investigated second- or third-line nab-paclitaxel either alone or in combination with CC-486 or durvalumab in patients with advanced NSCLC. The objective of this analysis is to report QoL outcomes in patients treated with nab-paclitaxel + durvalumab from the ABOUND.2L+ trial.
a9ded1e5ce5d75814730bb4caaf49419 Method
Enrolled patients were ≥ 18 years with advanced NSCLC and no more than 1 prior line of platinum-containing chemotherapy. Immunotherapy in a prior line, first or second, was allowed. Patients were treated with nab-paclitaxel on days 1 and 8 + durvalumab 1125 mg on day 15 of a 21-day cycle. Treatment continued until unacceptable toxicity or disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or immune-related RECIST v1.1. The primary endpoint was progression-free survival. QoL was a prespecified exploratory endpoint assessed using the Lung Cancer Symptom Scale (LCSS), EuroQol 5D-5L, and EORTC QLQ-C30 on day 1 of each cycle, and was examined through 6 cycles of treatment for this analysis.
4c3880bb027f159e801041b1021e88e8 Result
A total of 79 patients were assigned to the nab-paclitaxel + durvalumab arm. The median age was 63.0 years. Most patients were white (97.5%), male (68.4%), and had ECOG PS of 1 (77.2%). For the entire study, baseline and ≥ 1 postbaseline QoL assessments were completed by 58 (73.4%) patients. 41 patients completed 6 cycles of treatment with nab-paclitaxel + durvalumab. After cycle 6, the mean change from baseline in LCSS total score and pulmonary symptom score was 0.1 and −0.2, respectively. LCSS hemoptysis score improved relative to baseline at every treatment cycle; mean change from baseline after 6 cycles was 0.8. Mean change from baseline in the EuroQol 5D-5L visual analog scale score and EORTC QLQ-C30 global health status/QoL scale score after 6 cycles of treatment was 2.5 and −1.19, respectively.
8eea62084ca7e541d918e823422bd82e Conclusion
In general, patients with advanced NSCLC treated with second- or third-line nab-paclitaxel + durvalumab maintained their QoL through 6 cycles of treatment. NCT02250326.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P3.08 - Oligometastatic NSCLC (Not CME Accredited Session) (ID 974)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.08-06 - Long-Term Survival for Brain-Only Oligometastatic NSCLC Patients Treated with Ablative Therapy (AT): Prognostic Factors (ID 14119)
12:00 - 13:30 | Presenting Author(s): Óscar Juan-Vidal
- Abstract
Background
Although brain metastasis (BM) have been associated with poor prognosis,brain-only oligometastatic(BOO)-NSCLC patients represent a special population for whom CAT may represent a reasonable therapeutic approach
a9ded1e5ce5d75814730bb4caaf49419 Method
Retrospective cohort with BOO-NSCLC (defined as 1-5 metastases in brain as only metastatic site) treated between 2010-2018 at Hospital La-Fe.Recursive Partitioning Analysis (RPA) group-score was calculated
4c3880bb027f159e801041b1021e88e8 Result
67 patients were identified (Table-1). Median-overall survival (mOS) was 20.2 months (95CI%:11.5-28.9). RPA-group score was associated with OS (HR:5.7;p<0.001); mOS was not reached in RPA-I, 16.2 m (95%CI:8.3-24.1) in RPA-II and 4.5 m ((IC95%:2.2-6.8) in RPA-III. Other factors associated with OS in univariable analysis were: radical treatment of the primary tumor (HR:2.6,p<0.005); radical treatment of the BM (HR:5.6,p<0,001); lymph node involvement (HR:2.17,p=0.031).Radical treatment in both primary and BM was associated with an increased mOS (HR:2.62;p<0,001). In the multivariable model, only RPA-group (HR:1.8 CI95%:2.8-12.7;p<0.0001), radical treatment of BM (HR:1.7;CI95%:2.4-13.1;p<0.0001) and lymph node involvement (HR:0.82;CI95%:1.1-4.9;p=0.03) were associated with an improved survival(table-2).
Table-1.Patients´ characteristics
VARIABLES
ALL PATIENTS
NUMBER
%
Patients enrolled
67
100
Gender
Male
Female
48
19
71.6
28.4
Age
Median (range)
59 (40-85)
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Pathology
Adenocarcinoma
Squamous
NSCLC NOS
49
8
10
73.1
11.9
14.9
RPA groups
RPA-I
RPA-II
RPA-III
19
39
9
28.4
58.2
9
Brain metastases
Synchronous to diagnosis
Metachronous to diagnosis
47
20
70.1
29.9
Number of brain metastases
1
2
3
4-5
46
11
4
6
68.7
16.4
6
9
Table-2.Univariate and multivariate analysis.
Variable
Survival (months)
Univariate
Multivariate
HR
IC95%
p-value
HR
IC95%
p-value
RPA-I
Not reach
5.7
Not reach
<0.001
1.8
2.8-12.7
<0.0001
RPA-II
16.2
8.3-24.1
RPA-III
4.5
2.2-6.8
Radical treatment of the primary tumor
31.4
2.6
13.7-49.1
<0.005
0.4
0.8-3.4
0.2
No radical treatment of the primary tumor
8.4
3.0-14.4
One BM
24.5
8.7-40.4
>0.5
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More than one BM
11.4
1-22
radical treatment of the BM
36.2
5.6
15.2-57.2
< 0,001
1.7
2.4-13.1
<0.0001
No radical treatment of the BM
6.5
5.8-7.3
N0-N1
36.7
2.7
Not reach
p=0.031
0.82
1.1-4.9
0.03
N2-N3
16.2
5.2-27.3
Radical treatment in both primary and BM
36.2
2.62
28.1-44.4
<0,001
0.8
0.55-10.69
0.25
No radical treatment in both primary and BM
7.2
3.9-10.5
A radical approach in patients with stage-IV NSCLC with a limited number of BM may achieve long-term disease control in a subgroup of patients. Patients with RPA-I and II, one-BM, radical treatment, and N0-N1 have improved OS and may be suitable for this approach
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