Quality of life (QoL) in metastatic breast cancer patients with. maintenance paclitaxel plus gemcitabine (PG) chemotherapy:

Transcription

1 Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02) Yeon Hee Park 1, Kyung Hae Jung 2, Seock-Ah Im 3, Joo Hyuk Sohn 4, Jungsil Ro 5, Jin-Hee Ahn 2, Sung-Bae Kim 2, Byung-Ho Nam 6, Do Youn Oh 3, Sae-Won Han 3, Soohyeon Lee 4, In Hae Park 5, Keun Seok Lee 5, Jee Hyun Kim 7, Seok Yun Kang 8, Moon Hee Lee 9, Hee Sook Park 10, Sook Young Woo 11, Sin-Ho Jung 11, Jin Seok Ahn 1, Young-Hyuck Im 1 ; Korean Cancer Study Group (KCSG) 1 Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea 2 Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea 3 Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea 4 Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea 5 Center for Breast Cancer, National Cancer Center, Goyang, Korea 6 Biometric Research Branch, National Cancer Center, Goyang, Korea 7 Department of Internal Medicine, Seoul National University Bundang Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seongnam, Korea 8 Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea 9 Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea

2 10 Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Hospital, Seoul, Korea 11 Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Running Head: HRQoL between Maintenance PG Chemotherapy and Observation for MBC Corresponding author: Young-Hyuck Im Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnamgu, Seoul , Korea. Tel: , Fax:

3 Supplementary Table 1 Patients characteristics between maintenance and observation arm Maintenance (%) Observation (%) p value (n=116) (n=115) Median age (range) 48 (30-70) 47 (29-76) (T-test) ECOG PS (50.4) 55 (47.8) 2 (1.7) 57 (49.1) 57 (49.1) 2 (1.7) Menopausal status Pre Post Unknown 56 (48.3) 56 (48.3) 4 (3.4) 53 (46.1) 60 (52.2) 2 (1.7) IDC vs. others 107 (92.2) 112 (97.4) HR-positive 85 (73.3) 87 (75.7) HR-negative 31 (26.7) 28 (24.3) HER2-positive 2 (1.7) 2 (1.7) Number of metastatic sites (27.6) 37 (31.9) 47 (40.5) 38 (33.0) 44 (38.3) 33 (28.7) Metastatic sites Distant lymph nodes Lung- hematogeneous Lung- lymphangitic Liver Bone Pleura Others 78 (67.2) 37(31.9) 26 (22.4) 41 (35.3) 53 (45.7) 21 (18.1) 2 (1.7) 62 (53.9) 19 (16.5) 31 (27.0) 34 (29.6) 50 (43.5) 12 (10.4) 1 (0.9) Visceral metastases 81 (69.8) 74 (64.3) Prior adjuvant chemotherapy Anthracycline Taxane 67 (57.8) 42 (36.2) 57 (49.6) 38 (33.0%) Prior adjuvant endocrine 53 (45.7) 42 (36.5) therapy Palliative endocrine therapy before PG chemotherapy 26 (22.4) 20 (17.4) IQR interquartile range, IDC invasive ductal carcinoma, HR-positive ER-positive and/or PgR-positive, HR-negative ER-negative and PgR-negative

4 Supplementary Table 2 Comparison of QLQ-C30 between the two groups at each cycle (t-test) Cycles ALOCRNDM N Mean Std Dev Std Err Minimum Maximum Method Variances DF t Value p value A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B

5 Supplementary Table 3 Comparision PFRF between maintenance and observation group Parameter Estimate Standard Error 95% Confidence Limits Z p value Intercept < ALOCRNDM A(ref) vs B Cycles Cycles*ALOCRNDM A(ref) vs B

6 Supplementary Table 4 Comparison of PFRF between the two groups at each cycle (t-test) Cycles ALOCRNDM N Mean Std Dev Std Err Minimum Maximum Method Variances DF t Value p value A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B

7 Supplementary Table 5 Comparision ECSF between maintenance and observation group Parameter Estimate Standard Error 95% Confidence Limits Z p value Intercept < ALOCRNDM A(ref) vs B Cycle Cycle*ALOCRNDM A(ref) vs B

8 Supplementary Table 6 Comparison of ECSF between the two groups at each cycle (t-test) Cycle ALOCRNDM N Mean Std Dev Std Err Minimum Maximum Method Variances DF t Value p value A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B

9 Supplementary Table 7 Comparision QL2 between maintenance and observation group Parameter Estimate Standard Error 95% Confidence Limits Z p value Intercept < ALOCRNDM A(ref) vs B Cycle Cycle*ALOCRNDM A(ref) vs B

10 Supplementary Table 8 Comparision SS1 between maintenance and observation group Standard 95% Confidence Parameter Estimate Z Error Limits p value Intercept < ALOCRNDM A(ref) vs B) Cycle Cycle*ALOCRNDM A(ref) vs B

11 Supplementary Table 9. Comparison of SS1 between the two groups at each cycle (t-test) Cycle ALOCRNDM N Mean Std Dev Std Err Minimum Maximum Method Variances DF t Value p value A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B

12 Supplementary Table 10 Comparison of SS2 between the two groups at each cycle (t-test) Parameter Estimate Standard Error 95% Confidence Limits Z p value Intercept < ALOCRNDM A(ref) vs B Cycle Cycle*ALOCRNDM A(ref) vs B

13 Supplementary Table 11 Comparison of SS2 between the two groups at each cycle (t-test) Cycle ALOCRNDM N Mean Std Dev Std Err Minimum Maximum Method Variances DF t Value Pr > t A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B

14 Supplementary Table 12 Comparison of BR23 between the two groups at each cycle (t-test) Cycles ALOCRNDM N Mean Std Dev Std Err Minimum Maximum Method Variances DF t Value Pr > t 0 A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B A Pooled Equal B