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Carboplatin in Elderly Patients with NSCLC (ABOUND.70+): Analysis of Safety and Quality of Life (QoL) by Cycle
November 2017
Abstracts
medication) + (3 %diffusing capacity of the lung carbon monoxide [<50%]). Patients were then classified into three groups. The AE rate was 12% for a risk score of 0e5, 47% for a score of 6e10, and 66.7% for a score 11. This sensitivity of the scoring system was 78.6%, and specificity was 67.8%. Conclusion: The present scoring system could identify IP patients at high risk for AE after chemotherapy for lung cancer. Keywords: lung cancer associated with interstitial pneumonia, risk score, acute exacerbation
P2.01-011 The Efficiency and Safety of Apatinib plus S-1 as Second-Line or Laterline Chemotherapy for Advanced Squamous Cell Lung Carcinoma Q. Shi,1 X. Guo,2 Z. Wang,3 X. Cheng,4 L. Xia,5 X. Li,6 W. Hu,7 F. Zhao,8 Y. Liu,2 J. Wang,2 F. Wang7 1Anhui Chest Hospital, Hefei/CN, 2Fuyang Cancer Hospital, Fuyang/CN, 3The First Affiliated Hospital of Bengbu Medical College, Bengbu/CN, 4Anhui No.2 Province People ’S Hospital, Hefei/CN, 5Anhui Provincial Hospital of Traditional Chinese Medicine, Hefei/CN, 6The People’s Hospital, huaibei, Huaibei/CN, 7Tongling People’s Hospital, Tongling/CN, 8No.2 Hospital of Fuyang City, Fuyang/CN Background: There is no standard treatment strategy for patients with advanced squamous cell lung carcinoma who experienced progression with one or more lines of chemotherapy. Apatinib, a new tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2), has been shown confirming antitumor activity and manageable toxicities in gastric cancers and other solid tumor. Moreover, clinical trials of S-1 on squamous cell lung carcinoma shows curative effect and lighter adverse reactions. This prospective study tried to investigate the efficacy and safety of apatinib plus S-1 as second- or third-line treatment in patients with advanced squamous cell lung carcinoma. Method: In this open-label single-arm study(ChiCTROPC-16009048), patients were treated oral apatinib, at a dose of 250500 mg daily, and S-1, at a dose of 60mg/m2 daily D1-14, repeat every 3 weeks, in the second- or third-line setting. The primary endpoint was progression-free-survival (PFS) and the tumor response was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Treatment was continued until disease progression or unacceptable toxicity occurs. Result: From August 19, 2016 to May 31, 2017, 16 patients were enrolled. In 16 patients, there were 7 patients available for efficiency evaluation and 12 patients available for safety evaluation. Computed tomography (CT) scan evaluation revealed that partial response (PR) occurred in 1 of 7 patients and other 6 showed stable disease (SD). However with 2 patients of 6 patients showed stable disease (SD), the tumor demonstrates central cavitation. Hypertension is one of the most frequent adverse reactions, which appeared in 3 of 12 patients who were getting to be normal under oral antihypertensive agent. Others like hand-foot syndrome, proteinuria, diarrhea and fatigue appeared in 1 of 12 patients respectively and could be better controlled. No treatment-related hemorrhage occurred. Conclusion: Apatinib plus S-1 exhibits superior activity and acceptable toxicity for evaluable patients with advanced squamous cell lung carcinoma. The research team will continue the study.
P2.01-012 Impact of Brain Metastases on the Humanistic Burden Incurred by Patients with Advanced Non-small Cell Lung Cancer (A-nsclc) 1
1
2
3 1
G. Taylor-Stokes, R. Wood, M. Lees, O. Chirita Adelphi Real World, Macclesfield/GB, 2Bristol-Myers Squibb, Rueil-Malmaison/FR, 3 Bristol-Myers Squibb, Uxbridge/GB Background: It is well documented that brain metastases negatively impact the prognosis for patients with A-NSCLC. However, it is less well
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known how secondary brain tumors impact health status, quality of life (QoL) and productivity in these patients. As such, an analysis of data from A-NSCLC patients was conducted to evaluate whether the metastatic site (brain vs non-brain) impacts the burden of disease. Method: Data were collected between May 2015 and June 2016 from adult patients with Stage IIIB or IV NSCLC via medical chart reviews and patient self-completion forms as part of a multicenter, cross-sectional study conducted in France, Germany and Italy. Health status was measured using the EQ-5D-3L (including the visual analogue scale, EQVAS), QoL using the EORTC QLQ-C30 and work/activity impairment using the WPAI:GH questionnaire. Outcomes were stratified by metastatic site (brain vs non-brain); no adjustments were made for possible confounding factors. Statistical significance was assessed using ManneWhitney U tests. Result: 1030 patients were recruited: mean patient age, 64.5 years; male, 65.9%; current/former smokers, 77.9%. Most patients had Stage IV NSCLC (88.4%), non-squamous histology (70.3%) and/or were receiving first-line therapy (70.5%). Patients were largely receiving chemotherapy, regardless of line of therapy. Of 910 evaluable Stage IV patients, 111 had brain metastases and 799 had non-brain metastases. Significant differences were observed between patients with brain metastases versus non-brain metastases for health status, QoL and activity-related impairments (Table). The percentage of work-related impairment was also numerically higher in patients with brain metastases. Conclusion: Patients with A-NSCLC and secondary brain tumors had significantly worse health status and QoL, and experienced greater work- and activity-related impairments, compared with A-NSCLC patients with non-brain metastases. These findings may indicate a need for specific management/support programs for patients with A-NSCLC and brain metastases. Keywords: Advanced Non-Small Cell Lung Cancer, quality of life, brain metastases
P2.01-013 Nab-Paclitaxel/Carboplatin in Elderly Patients with NSCLC (ABOUND.70+): Analysis of Safety and Quality of Life (QoL) by Cycle E. Kim,1 J. Weiss,2 E. Anderson,3 R. Jotte,4 J.W. Goldman,5 D. Haggstrom,1 D. Smith,6 C. Dakhil,7 K. Konduri,8 T. Berry,9 T.J. Ong,9 A. Sanford,9 K. Amiri,9 C. Langer10 1Levine Cancer Institute; Carolinas Healthcare System, Charlotte/NC/US, 2Unc Lineberger Comprehensive Cancer Center, Chapel Hill/NC/US, 3Knight Cancer Institute, Oregon Health and Science University, Portland/OR/US, 4Rocky Mountain Cancer Centers, Denver/CO/US, 5David Geffen School of Medicine at UCLA, Los Angeles/CA/US, 6Compass Oncology, Vancouver/ CA, 7Cancer Center of Kansas, Wichita/KS/US, 8Baylor Charles A. Sammons Cancer Center; Texas Oncology Pa, Dallas/TX/US, 9Celgene Corporation, Summit/NJ/US, 10Abramson Cancer Center, University of Pennsylvania, Philadelphia/PA/US Background: ABOUND.70+ evaluated 2 schedules of first-line nabpaclitaxel/carboplatin in patients 70 years with advanced NSCLC to determine whether a 1-week break can improve tolerability. Safety and QoL by cycle are reported. Method: Patients 70 years with locally advanced/metastatic NSCLC were randomized to first-line nab-paclitaxel 100mg/m2 on d1, 8, 15 and carboplatin AUC 6 on d1 of a 21d cycle (Arm A) or the same regimen with a 1-week break between
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Journal of Thoracic Oncology
cycles (Arm B). Primary endpoint: percentage of patients with grade 2 peripheral neuropathy (PN) or grade 3 myelosuppression (laboratory values). QoL (exploratory endpoint) was assessed using Lung Cancer Symptom Scale (LCSS) on d1 of each cycle. Safety analyzes included patients receiving 1 dose of study medication. AEs/QoL were analyzed at each of the first 6 cycles. Result: At interim evaluation, primary endpoint was similar across arms, resulting in early closure of enrollment. Of 143 randomized patients, 68 and 70 in Arms A and B received 1 dose of study drug. Table lists primary endpoint and key safety results by cycle. Grade 2 PN occurred earlier in Arm A. Incidence of grade 3 myelosuppression was highest in the first 2 cycles, progressively declining after cycle 3 (both arms). Dose reductions occurred in earlier cycles for Arm A; at the start of cycle 4, 36% vs 47% of patients received the maximum dose (100mg/m2) of nab-paclitaxel in Arms A and B. Generally, QoL was maintained throughout treatment. LCSS item of cough improved with each cycle; mean change from baseline at the end of cycle 6 was 25.4 and 13.8mm (visual analog scale). Conclusion: Although the overall rate of grade 2 PN and grade 3 myelosuppression was similar between arms, analysis by cycle showed that grade 2 PN and dose reductions occurred earlier in Arm A. QoL was maintained in both arms. NCT02151149. Keywords: elderly, NSCLC, nab-paclitaxel
Safety Primary endpoint, % P value Peripheral neuropathy, % All cycles Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 Myelosuppression, % All cycles Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 a
Arm A n ¼ 68
Arm B n ¼ 70
76
77
0.9258 Grade 2a 37 6 6 7 4 6 4 Grade 3 71 35 22 3 6 1 3
Grade 3a
Grade 2a
Grade 3a
13 0 4 4 0 3 1
36 0 1 9 7 4 4 Grade 3 64 37 10 10 1 3 3
17 0 0 1 1 1 9
Calculated by first occurrence of adverse event of respective grade.
Vol. 12 No. 11S2
data exist from recent, randomized prospective trials. ABOUND.PS2 evaluated the safety and efficacy of nab-paclitaxel/carboplatin induction followed by nab-paclitaxel monotherapy in patients with advanced NSCLC and ECOG PS 2. Method: Chemotherapy-naive patients with histologically/cytologically confirmed stage IIIB/IV NSCLC and ECOG PS 2 received 4 cycles of nab-paclitaxel 100 mg/m2 on days 1 and 8 plus carboplatin AUC 5 on day 1 q3w. Patients not progressing could receive monotherapy with nab-paclitaxel 100 mg/m2 on days 1 and 8 q3w until progression or unacceptable toxicity. Primary endpoint: percentage of patients discontinuing within the first 4 cycles due to treatment-emergent adverse events (TEAEs). Other endpoints: progression-free survival (PFS), disease control rate (DCR), overall survival (OS), overall response rate (ORR), and quality of life (QoL) by Lung Cancer Symptom Score (LCSS). Result: Forty patients were treated. Median age was 67.5 years, 60.0% were male, 92.5% were white, and 62.5% had nonsquamous histology. During induction, 11 of 40 patients (28%) discontinued due to TEAEs (primary endpoint). In total, 16 of 40 patients (40.0%) received nab-paclitaxel as monotherapy. In all treated patients, the median percentage of per-protocol dose of nab-paclitaxel was 78.3% and the median nab-paclitaxel dose intensity was 52.2 mg/ m2/week (planned, 66.7 mg/m2/week). See table for additional safety, efficacy, and QoL results. Conclusion: These results support the role of this nab-paclitaxelebased regimen in patients with NSCLC and ECOG PS 2. The regimen was well tolerated and appears to have resulted in a clinically meaningful improvement in QoL. Compared with historical data, this regimen is active in patients with stage IIIB/IV NSCLC and ECOG PS 2. NCT02289456. Keywords: performance status, nab-paclitaxel, NSCLC
All Treated Patients N ¼ 40 Safety Grade ‡ 3 TEAEs of special interest, n (%) Neutropenia Anemia Thrombocytopenia Peripheral neuropathy Efficacy PFS, median (95% CI), months OS, median (95% CI), months ORR (RECIST v1.1), n (%) DCR, % Complete response Partial response Stable disease Progressive disease, % Patients with no postbaseline tumor assessment QoL Mean maximum improvement from baseline LCSS Global QoL item, mma a
9 (22.5) 7 (17.5) 2 (5.0) 1 (2.5)
4.4 (2.99-7.00) 7.66 (4.93-13.17) 12 (30.0) 30 (75.0) 0 12 (30.0) 18 (45.0) 2 (5.0) 8 (20.0)
16.91
A 10-mm improvement was considered clinically meaningful.
P2.01-014 ABOUND.PS2: Safety and Efficacy of NabPaclitaxeleBased Therapy in Patients with NSCLC and ECOG PS 2
P2.01-015 Longitudinal Assessment of Performance Status (PS) in Patients with NSCLC and ECOG PS 2 on NabPaclitaxeleBased Therapy
A. Gajra,1 N. Abdel Karim,2 D. Mulford,3 M. Matrana,4 H. Ali,5 E. Santos,6 T.J. Ong,7 A. Sanford,7 K. Amiri,7 D. Spigel8 1Upstate Medical University, State University of New York, Syracuse, NY/US, 2 University of Cincinnati Medical Center, Cincinnati, OH/US, 3University of Rochester Medical Center, James P. Wilmot Cancer Center, Rochester, NY/US, 4Ochsner Medical Center, New Orleans, LA/US, 5Henry Ford Health System, Detroit, MI/US, 6Eugene M. and Christine E. Lynn Cancer Institute, Boca Raton, FL/US, 7Celgene Corporation, Summit, NJ/US, 8 Sarah Cannon Research Institute, Nashville, TN/US
N. Abdel Karim,1 D. Mulford,2 M. Matrana,3 H. Ali,4 E. Santos,5 T.J. Ong,6 A. Sanford,6 K. Amiri,6 D. Spigel,7 A. Gajra8 1University of Cincinnati Medical Center, Cincinnati, OH/US, 2University of Rochester Medical Center, James P. Wilmot Cancer Center, Rochester, NY/US, 3 Ochsner Medical Center, New Orleans, LA/US, 4Henry Ford Health System, Detroit, MI/US, 5Eugene M. and Christine E. Lynn Cancer Institute, Boca Raton, FL/US, 6Celgene Corporation, Summit, NJ/US, 7 Sarah Cannon Research Institute, Nashville, TN/US, 8Upstate Medical University, State University of New York, Syracuse, NY/US
Background: Patients with advanced NSCLC with poor ECOG PS can benefit from platinum-based doublet chemotherapy, although limited
Background: ABOUND.PS2 evaluated nab-paclitaxel/carboplatin induction followed by nab-paclitaxel monotherapy in patients with
Abstracts
medication) + (3 %diffusing capacity of the lung carbon monoxide [<50%]). Patients were then classified into three groups. The AE rate was 12% for a risk score of 0e5, 47% for a score of 6e10, and 66.7% for a score 11. This sensitivity of the scoring system was 78.6%, and specificity was 67.8%. Conclusion: The present scoring system could identify IP patients at high risk for AE after chemotherapy for lung cancer. Keywords: lung cancer associated with interstitial pneumonia, risk score, acute exacerbation
P2.01-011 The Efficiency and Safety of Apatinib plus S-1 as Second-Line or Laterline Chemotherapy for Advanced Squamous Cell Lung Carcinoma Q. Shi,1 X. Guo,2 Z. Wang,3 X. Cheng,4 L. Xia,5 X. Li,6 W. Hu,7 F. Zhao,8 Y. Liu,2 J. Wang,2 F. Wang7 1Anhui Chest Hospital, Hefei/CN, 2Fuyang Cancer Hospital, Fuyang/CN, 3The First Affiliated Hospital of Bengbu Medical College, Bengbu/CN, 4Anhui No.2 Province People ’S Hospital, Hefei/CN, 5Anhui Provincial Hospital of Traditional Chinese Medicine, Hefei/CN, 6The People’s Hospital, huaibei, Huaibei/CN, 7Tongling People’s Hospital, Tongling/CN, 8No.2 Hospital of Fuyang City, Fuyang/CN Background: There is no standard treatment strategy for patients with advanced squamous cell lung carcinoma who experienced progression with one or more lines of chemotherapy. Apatinib, a new tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2), has been shown confirming antitumor activity and manageable toxicities in gastric cancers and other solid tumor. Moreover, clinical trials of S-1 on squamous cell lung carcinoma shows curative effect and lighter adverse reactions. This prospective study tried to investigate the efficacy and safety of apatinib plus S-1 as second- or third-line treatment in patients with advanced squamous cell lung carcinoma. Method: In this open-label single-arm study(ChiCTROPC-16009048), patients were treated oral apatinib, at a dose of 250500 mg daily, and S-1, at a dose of 60mg/m2 daily D1-14, repeat every 3 weeks, in the second- or third-line setting. The primary endpoint was progression-free-survival (PFS) and the tumor response was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Treatment was continued until disease progression or unacceptable toxicity occurs. Result: From August 19, 2016 to May 31, 2017, 16 patients were enrolled. In 16 patients, there were 7 patients available for efficiency evaluation and 12 patients available for safety evaluation. Computed tomography (CT) scan evaluation revealed that partial response (PR) occurred in 1 of 7 patients and other 6 showed stable disease (SD). However with 2 patients of 6 patients showed stable disease (SD), the tumor demonstrates central cavitation. Hypertension is one of the most frequent adverse reactions, which appeared in 3 of 12 patients who were getting to be normal under oral antihypertensive agent. Others like hand-foot syndrome, proteinuria, diarrhea and fatigue appeared in 1 of 12 patients respectively and could be better controlled. No treatment-related hemorrhage occurred. Conclusion: Apatinib plus S-1 exhibits superior activity and acceptable toxicity for evaluable patients with advanced squamous cell lung carcinoma. The research team will continue the study.
P2.01-012 Impact of Brain Metastases on the Humanistic Burden Incurred by Patients with Advanced Non-small Cell Lung Cancer (A-nsclc) 1
1
2
3 1
G. Taylor-Stokes, R. Wood, M. Lees, O. Chirita Adelphi Real World, Macclesfield/GB, 2Bristol-Myers Squibb, Rueil-Malmaison/FR, 3 Bristol-Myers Squibb, Uxbridge/GB Background: It is well documented that brain metastases negatively impact the prognosis for patients with A-NSCLC. However, it is less well
S2073
known how secondary brain tumors impact health status, quality of life (QoL) and productivity in these patients. As such, an analysis of data from A-NSCLC patients was conducted to evaluate whether the metastatic site (brain vs non-brain) impacts the burden of disease. Method: Data were collected between May 2015 and June 2016 from adult patients with Stage IIIB or IV NSCLC via medical chart reviews and patient self-completion forms as part of a multicenter, cross-sectional study conducted in France, Germany and Italy. Health status was measured using the EQ-5D-3L (including the visual analogue scale, EQVAS), QoL using the EORTC QLQ-C30 and work/activity impairment using the WPAI:GH questionnaire. Outcomes were stratified by metastatic site (brain vs non-brain); no adjustments were made for possible confounding factors. Statistical significance was assessed using ManneWhitney U tests. Result: 1030 patients were recruited: mean patient age, 64.5 years; male, 65.9%; current/former smokers, 77.9%. Most patients had Stage IV NSCLC (88.4%), non-squamous histology (70.3%) and/or were receiving first-line therapy (70.5%). Patients were largely receiving chemotherapy, regardless of line of therapy. Of 910 evaluable Stage IV patients, 111 had brain metastases and 799 had non-brain metastases. Significant differences were observed between patients with brain metastases versus non-brain metastases for health status, QoL and activity-related impairments (Table). The percentage of work-related impairment was also numerically higher in patients with brain metastases. Conclusion: Patients with A-NSCLC and secondary brain tumors had significantly worse health status and QoL, and experienced greater work- and activity-related impairments, compared with A-NSCLC patients with non-brain metastases. These findings may indicate a need for specific management/support programs for patients with A-NSCLC and brain metastases. Keywords: Advanced Non-Small Cell Lung Cancer, quality of life, brain metastases
P2.01-013 Nab-Paclitaxel/Carboplatin in Elderly Patients with NSCLC (ABOUND.70+): Analysis of Safety and Quality of Life (QoL) by Cycle E. Kim,1 J. Weiss,2 E. Anderson,3 R. Jotte,4 J.W. Goldman,5 D. Haggstrom,1 D. Smith,6 C. Dakhil,7 K. Konduri,8 T. Berry,9 T.J. Ong,9 A. Sanford,9 K. Amiri,9 C. Langer10 1Levine Cancer Institute; Carolinas Healthcare System, Charlotte/NC/US, 2Unc Lineberger Comprehensive Cancer Center, Chapel Hill/NC/US, 3Knight Cancer Institute, Oregon Health and Science University, Portland/OR/US, 4Rocky Mountain Cancer Centers, Denver/CO/US, 5David Geffen School of Medicine at UCLA, Los Angeles/CA/US, 6Compass Oncology, Vancouver/ CA, 7Cancer Center of Kansas, Wichita/KS/US, 8Baylor Charles A. Sammons Cancer Center; Texas Oncology Pa, Dallas/TX/US, 9Celgene Corporation, Summit/NJ/US, 10Abramson Cancer Center, University of Pennsylvania, Philadelphia/PA/US Background: ABOUND.70+ evaluated 2 schedules of first-line nabpaclitaxel/carboplatin in patients 70 years with advanced NSCLC to determine whether a 1-week break can improve tolerability. Safety and QoL by cycle are reported. Method: Patients 70 years with locally advanced/metastatic NSCLC were randomized to first-line nab-paclitaxel 100mg/m2 on d1, 8, 15 and carboplatin AUC 6 on d1 of a 21d cycle (Arm A) or the same regimen with a 1-week break between
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Journal of Thoracic Oncology
cycles (Arm B). Primary endpoint: percentage of patients with grade 2 peripheral neuropathy (PN) or grade 3 myelosuppression (laboratory values). QoL (exploratory endpoint) was assessed using Lung Cancer Symptom Scale (LCSS) on d1 of each cycle. Safety analyzes included patients receiving 1 dose of study medication. AEs/QoL were analyzed at each of the first 6 cycles. Result: At interim evaluation, primary endpoint was similar across arms, resulting in early closure of enrollment. Of 143 randomized patients, 68 and 70 in Arms A and B received 1 dose of study drug. Table lists primary endpoint and key safety results by cycle. Grade 2 PN occurred earlier in Arm A. Incidence of grade 3 myelosuppression was highest in the first 2 cycles, progressively declining after cycle 3 (both arms). Dose reductions occurred in earlier cycles for Arm A; at the start of cycle 4, 36% vs 47% of patients received the maximum dose (100mg/m2) of nab-paclitaxel in Arms A and B. Generally, QoL was maintained throughout treatment. LCSS item of cough improved with each cycle; mean change from baseline at the end of cycle 6 was 25.4 and 13.8mm (visual analog scale). Conclusion: Although the overall rate of grade 2 PN and grade 3 myelosuppression was similar between arms, analysis by cycle showed that grade 2 PN and dose reductions occurred earlier in Arm A. QoL was maintained in both arms. NCT02151149. Keywords: elderly, NSCLC, nab-paclitaxel
Safety Primary endpoint, % P value Peripheral neuropathy, % All cycles Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 Myelosuppression, % All cycles Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 a
Arm A n ¼ 68
Arm B n ¼ 70
76
77
0.9258 Grade 2a 37 6 6 7 4 6 4 Grade 3 71 35 22 3 6 1 3
Grade 3a
Grade 2a
Grade 3a
13 0 4 4 0 3 1
36 0 1 9 7 4 4 Grade 3 64 37 10 10 1 3 3
17 0 0 1 1 1 9
Calculated by first occurrence of adverse event of respective grade.
Vol. 12 No. 11S2
data exist from recent, randomized prospective trials. ABOUND.PS2 evaluated the safety and efficacy of nab-paclitaxel/carboplatin induction followed by nab-paclitaxel monotherapy in patients with advanced NSCLC and ECOG PS 2. Method: Chemotherapy-naive patients with histologically/cytologically confirmed stage IIIB/IV NSCLC and ECOG PS 2 received 4 cycles of nab-paclitaxel 100 mg/m2 on days 1 and 8 plus carboplatin AUC 5 on day 1 q3w. Patients not progressing could receive monotherapy with nab-paclitaxel 100 mg/m2 on days 1 and 8 q3w until progression or unacceptable toxicity. Primary endpoint: percentage of patients discontinuing within the first 4 cycles due to treatment-emergent adverse events (TEAEs). Other endpoints: progression-free survival (PFS), disease control rate (DCR), overall survival (OS), overall response rate (ORR), and quality of life (QoL) by Lung Cancer Symptom Score (LCSS). Result: Forty patients were treated. Median age was 67.5 years, 60.0% were male, 92.5% were white, and 62.5% had nonsquamous histology. During induction, 11 of 40 patients (28%) discontinued due to TEAEs (primary endpoint). In total, 16 of 40 patients (40.0%) received nab-paclitaxel as monotherapy. In all treated patients, the median percentage of per-protocol dose of nab-paclitaxel was 78.3% and the median nab-paclitaxel dose intensity was 52.2 mg/ m2/week (planned, 66.7 mg/m2/week). See table for additional safety, efficacy, and QoL results. Conclusion: These results support the role of this nab-paclitaxelebased regimen in patients with NSCLC and ECOG PS 2. The regimen was well tolerated and appears to have resulted in a clinically meaningful improvement in QoL. Compared with historical data, this regimen is active in patients with stage IIIB/IV NSCLC and ECOG PS 2. NCT02289456. Keywords: performance status, nab-paclitaxel, NSCLC
All Treated Patients N ¼ 40 Safety Grade ‡ 3 TEAEs of special interest, n (%) Neutropenia Anemia Thrombocytopenia Peripheral neuropathy Efficacy PFS, median (95% CI), months OS, median (95% CI), months ORR (RECIST v1.1), n (%) DCR, % Complete response Partial response Stable disease Progressive disease, % Patients with no postbaseline tumor assessment QoL Mean maximum improvement from baseline LCSS Global QoL item, mma a
9 (22.5) 7 (17.5) 2 (5.0) 1 (2.5)
4.4 (2.99-7.00) 7.66 (4.93-13.17) 12 (30.0) 30 (75.0) 0 12 (30.0) 18 (45.0) 2 (5.0) 8 (20.0)
16.91
A 10-mm improvement was considered clinically meaningful.
P2.01-014 ABOUND.PS2: Safety and Efficacy of NabPaclitaxeleBased Therapy in Patients with NSCLC and ECOG PS 2
P2.01-015 Longitudinal Assessment of Performance Status (PS) in Patients with NSCLC and ECOG PS 2 on NabPaclitaxeleBased Therapy
A. Gajra,1 N. Abdel Karim,2 D. Mulford,3 M. Matrana,4 H. Ali,5 E. Santos,6 T.J. Ong,7 A. Sanford,7 K. Amiri,7 D. Spigel8 1Upstate Medical University, State University of New York, Syracuse, NY/US, 2 University of Cincinnati Medical Center, Cincinnati, OH/US, 3University of Rochester Medical Center, James P. Wilmot Cancer Center, Rochester, NY/US, 4Ochsner Medical Center, New Orleans, LA/US, 5Henry Ford Health System, Detroit, MI/US, 6Eugene M. and Christine E. Lynn Cancer Institute, Boca Raton, FL/US, 7Celgene Corporation, Summit, NJ/US, 8 Sarah Cannon Research Institute, Nashville, TN/US
N. Abdel Karim,1 D. Mulford,2 M. Matrana,3 H. Ali,4 E. Santos,5 T.J. Ong,6 A. Sanford,6 K. Amiri,6 D. Spigel,7 A. Gajra8 1University of Cincinnati Medical Center, Cincinnati, OH/US, 2University of Rochester Medical Center, James P. Wilmot Cancer Center, Rochester, NY/US, 3 Ochsner Medical Center, New Orleans, LA/US, 4Henry Ford Health System, Detroit, MI/US, 5Eugene M. and Christine E. Lynn Cancer Institute, Boca Raton, FL/US, 6Celgene Corporation, Summit, NJ/US, 7 Sarah Cannon Research Institute, Nashville, TN/US, 8Upstate Medical University, State University of New York, Syracuse, NY/US
Background: Patients with advanced NSCLC with poor ECOG PS can benefit from platinum-based doublet chemotherapy, although limited
Background: ABOUND.PS2 evaluated nab-paclitaxel/carboplatin induction followed by nab-paclitaxel monotherapy in patients with