1Eli Lilly and Company, Indianapolis, IN, USA
2Analysis Group, New York, NY, USA
3Analysis Group, Boston, MA, USA
4Eli Lilly and Company, Sydney, Australia
5Eli Lilly and Company, Taipei, Taiwan
6Eli Lilly and Company, Seoul, Korea
7Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
Copyright © 2017 by the Korean Cancer Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
This study was supported by Eli Lilly and Company. The following authors are employees of Eli Lilly and Company and may own company stock: G.C.C., A.M.L., N.R., R.C., and J.S.K.
Variable | No. (%) |
---|---|
MGC patient | 198 (100) |
Age at MGC diagnosis, mean±SD | 61.3±9.8 |
Age group at MGC diagnosis (yr) | |
25-44 | 12 (6.1) |
45-54 | 31 (15.7) |
55-64 | 73 (36.9) |
≥ 65 | 82 (41.4) |
Male | 146 (73.7) |
Body mass indexa), mean±SD (kg/m2) | 21.4±2.6 |
Smoking history | |
Non-smoker | 83 (41.9) |
Current smoker | 38 (19.2) |
Former smoker | 55 (27.8) |
Unknown | 22 (11.1) |
Alcohol consumption | |
No alcohol use | 68 (34.3) |
Light to moderate | 94 (47.5) |
Heavy | 18 (9.1) |
Unknown | 18 (9.1) |
History of Helicobacter pylori infection | 8 (4.0) |
Family history of gastric cancer | 13 (6.6) |
Charlson comorbidity index (CCI)b), mean±SD | 0.4±0.6 |
Common comorbidity | |
Chronic atrophic gastritis | 45 (22.7) |
Cardiovascular disease | 37 (18.7) |
Intestinal metaplasia | 28 (14.1) |
Diabetes without chronic complicationsc) | 24 (12.1) |
Chronic obstructive pulmonary diseasec) | 16 (8.1) |
Peptic ulcer diseasec) | 15 (7.6) |
Stage IV at MGC diagnosis | 193 (97.5) |
Disease classification at MGC diagnosis | |
Intestinal | 48 (24.2) |
Diffuse | 72 (36.4) |
Mixed | 13 (6.6) |
Unknown | 65 (32.8) |
Tumor location | |
Antrum and pylorus | 102 (51.5) |
Fundus and corpus | 48 (24.2) |
Gastric cardia | 25 (12.6) |
Esophagogastric junction | 11 (5.6) |
Whole stomach | 7 (3.5) |
Other | 1 (0.5) |
Unknown | 4 (2) |
Metastatic site | |
Peritoneum | 106 (53.5) |
Lymph nodes | 94 (47.5) |
Liver | 77 (38.9) |
Bone | 22 (11.1) |
Lung | 9 (4.5) |
Other | 9 (4.5) |
Tested for HER2/neu gene expressiond) | 84 (42.4) |
HER2 positive | 8 (9.5) |
HER2 negative | 75 (89.3) |
HER2 status unknown | 1 (1.2) |
MGC, metastatic and/or locally recurrent, unresectable gastric cancer; SD, standard deviation; HER2, human epidermal growth factor receptor 2.
a) Patients with weight less than 20 kg (n=1) were assumed to have the population average weight of 58 kg,
b) The CCI was calculated excluding any malignancy (including leukemia and lymphoma) and metastatic solid tumor,
c) Comorbidities contributing to the CCI are marked,
d) The proportions of patients with positive, negative, and unknown values for HER2/neu gene expression are only among the tested patients.
Variable | No. (%) |
---|---|
MGC patient | 198 (100) |
Patient who received first-line chemotherapy treatment | 198 (100) |
Patient who received second-line chemotherapy treatment | 159 (80.3) |
Patient who received third-line chemotherapy treatment | 46 (23.2) |
Patient who received BSC only after first-line | 39 (19.7) |
ECOG PS score of first-line patientsa) | |
0: Asymptomatic | 25 (12.6) |
1: Symptomatic but completely ambulatory | 151 (76.3) |
2: Symptomatic, < 50% in bed during the day | 19 (9.6) |
4: Bedbound | 2 (1.0) |
Unknown | 1 (0.5) |
First-line regimenb) | |
Fluoropyrimidine+platinum (+/- leucovorin) | 120 (60.6) |
Capecitabine+platinum | 29 (14.6) |
Single-agent fluoropyrimidine (+/- leucovorin) | 38 (19.2) |
Reason for initiating second-line therapy | 159 (100) |
Tumor progression | 152 (95.6) |
Toxicity of first-line therapy | 7 (4.4) |
ECOG PS score of second-line patientsa) | 159 (100) |
0: Asymptomatic | 16 (10.1) |
1: Symptomatic but completely ambulatory | 105 (66.0) |
2: Symptomatic, < 50% in bed during the day | 35 (22.0) |
Unknown | 3 (1.9) |
Second-line regimenb) | 159 (100) |
Single agent fluoropyrimidine (+/- leucovorin) | 35 (22.0) |
S-1 | 11 (6.9) |
Capecitabine | 9 (5.7) |
5-FU | 7 (4.4) |
Irinotecan+platinum and/or fluoropyrimidine (+/- leucovorin) | 31 (19.5) |
Irinotecan, 5-FU, leucovorin | 15 (9.4) |
Irinotecan, 5-FU | 10 (6.3) |
Fluoropyrimidine+platinum agent (+/- leucovorin) | 21 (13.2) |
Capecitabine+platinum agent | 9 (5.7) |
5-FU+platinum agent | 7 (4.4) |
S-1+platinum agent | 5 (3.1) |
Single-agent taxane | 13 (8.2) |
Docetaxel | 9 (5.7) |
Otherc) | 59 (37.1) |
ECOG score of third-line patient | 46 (100) |
0: Asymptomatic | 5 (10.9) |
1: Symptomatic but completely ambulatory | 25 (54.3) |
2: Symptomatic, < 50% in bed during the day | 16 (34.8) |
Unknown | 0 |
Third-line regimen | |
Single-agent fluoropyrimidine (+/- leucovorin) | 12 (26.1) |
Fluoropyrimidine+platinum agent (+/- leucovorin) | 11 (23.9) |
Single-agent taxane | 9 (19.6) |
Irinotecan+platinum and/or fluoropyrimidine (+/- leucovorin) | 7 (15.2) |
Other | 7 (15.2) |
MGC, metastatic and/or locally recurrent, unresectable gastric cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; 5-FU, 5-fluorouracil.
a) Karnofsky scores were converted to ECOG PS scores (100 [ECOG PS 0], 80-90 [ECOG PS 1], 60-70 [ECOG PS 2], 40-50 [ECOG PS 3], and 10-30 [ECOG PS 4]),
b) A patient could have received a maximum of four therapeutic agents,
c) Other regimens included: irinotecan or oxaliplatin (6.9%), leucovorin/irinotecan (6.3%), cisplatin (5.7%), cisplatin/docetaxel (3.1%), and various other agents received by fewer than 2% of patients.
Variable | First-line followed by BSC (n=39) | First-line followed by second-line (n=159) | p-valuea) |
---|---|---|---|
Age at MGC diagnosis (yr) | |||
Years | 64.5±9.3 | 60.5±9.8 | 0.012* |
Median (Q1-Q3) | 66 (60-71) | 62 (55-67) | |
Distribution (yr) | |||
25-34 | 1 (2.6) | 3 (1.9) | > 0.990 |
35-44 | 0 | 8 (5.0) | 0.360 |
45-54 | 5 (12.8) | 26 (16.4) | 0.587 |
55-64 | 11 (28.2) | 62 (39.0) | 0.211 |
≥ 65 | 22 (56.4) | 60 (37.7) | 0.034* |
Male | 31 (79.5) | 115 (72.3) | 0.363 |
Ethnicity | |||
East Asian | 39 (100) | 159 (100) | > 0.990 |
BMI (kg/m2)b) | 21.8±2.8 | 21.3±2.5 | 0.121 |
Smoking history | |||
Non-smoker | 18 (46.2) | 65 (40.9) | 0.550 |
Current smoker | 9 (23.1) | 29 (18.2) | 0.492 |
Former smoker | 11 (28.2) | 44 (27.7) | 0.947 |
Unknown | 1 (2.6) | 21 (13.2) | 0.084 |
Alcohol consumption | |||
No alcohol use | 11 (28.2) | 57 (35.8) | 0.368 |
Light to moderate | 19 (48.7) | 75 (47.2) | 0.862 |
Heavy | 6 (15.4) | 12 (7.5) | 0.131 |
Unknown | 3 (7.7) | 15 (9.4) | > 0.990 |
Performance status (ECOG score)c) | |||
0: Asymptomatic | 1 (2.6) | 24 (15.1) | 0.033* |
1: Symptomatic but completely ambulatory | 31 (79.5) | 120 (75.5) | 0.597 |
2: Symptomatic, < 50% in bed during the day | 5 (12.8) | 14 (8.8) | 0.542 |
3: Symptomatic, > 50% in bed, but not bedbound | 0 | 0 | - |
4: Bedbound | 2 (5.1) | 0 | 0.038* |
Unknown | 0 | 1 (0.6) | > 0.990 |
Values are presented as mean±standard deviation or number (%) unless otherwise indicated. BSC, best supportive care; MGC, metastatic and/or locally recurrent, unresectable gastric cancer; BMI, body mass index; ECOG, Eastern Cooperative Oncology Group.
a) Chi-squared or Fisher exact tests for categorical variables, Wilcoxon rank sum tests for continuous variables. p-values of < 0.05 are indicated by an asterisk (*),
b) Patients weighing less than 20 kg (n=1) were assumed to have a population average weight of 58 kg,
c) Performance status was assessed at the beginning of first-line treatment.
Variable | First-line (n=198) | Second-line (n=159) | BSC, no second-linea) (n=39) | Third-line (n=46) |
---|---|---|---|---|
Supportive care | ||||
Antiemetics | 103 (52.0) | 71 (44.7) | 7 (17.9) | 21 (45.7) |
Analgesics | 74 (37.4) | 58 (36.5) | 9 (23.1) | 13 (28.3) |
Granulocyte-colony stimulating factors | 11 (5.6) | 13 (8.2) | 0 | 3 (6.5) |
Diuretics | 9 (4.5) | 6 (3.8) | 1 (2.6) | 1 (2.2) |
Antidepressants | 6 (3.0) | 4 (2.5) | 1 (2.6) | 0 |
Erythropoiesis stimulating agents | 4 (2.0) | 2 (1.3) | 0 | 0 |
GM-colony stimulating factors | 2 (1.0) | 0 | 0 | 0 |
Narcotics | 0 | 1 (0.6) | 0 | 0 |
Nutritional support | 27 (13.6) | 18 (11.3) | 4 (10.3) | 4 (8.7) |
Inpatient hospitalization | ||||
At least one stay | 71 (35.9) | 48 (30.2) | 13 (33.3) | 11 (23.9) |
No. of visits/patient | 3.5±3.4 | 2.1±1.4 | 2.5±2.5 | 3.7±2.0 |
Length of stay/hospitalization (day) | 8.2±9.4 | 9.1±11.3 | 14.3±15.6 | 10.2±12.5 |
Main reasons for visit | ||||
Chemotherapy infusion | 182 (73.4) | 68 (68.7) | 17 (53.1)b) | 23 (56.1) |
Disease symptom management | 38 (15.3) | 21 (21.2) | 9 (28.1) | 11 (26.8) |
Adverse events/toxicity | 19 (7.7) | 6 (6.1) | 2 (6.3) | 4 (9.8) |
Pain management | 2 (0.8) | 2 (2.0) | 3 (9.4) | 3 (7.3) |
Gastric cancer–related surgery | 6 (2.4) | 0 | 1 (3.1) | 0 |
Regular monitoring | 0 | 2 (2.0) | 0 | 0 |
Outpatient hospitalization (patients with information available) | 92 | 79 | 13 | 21 |
At least one visit | 59 (64.1) | 25 (31.6) | 4 (30.8) | 7 (33.3) |
Mean visits/patient | 3.2±4.3 | 2.5±3.3 | 1±0.0 | 2.7±2.5 |
Hospice unit (patients with information available) | 34 | 29 | 5 | 10 |
At least one stay | 1 (2.9) | 0 | 1 (20) | 2 (20.0) |
Oncologist clinic (patients with information available) | 127 | 102 | 25 | 28 |
At least one visit | 86 (67.7) | 60 (58.8) | 9 (36) | 10 (35.7) |
No. of visits/patient | 3.9±3.3 | 3.0±3.6 | 5.1±5.2 | 2.8±1.9 |
Values are presented as number (%) or mean±standard deviation unless otherwise indicated. BSC, best supportive care; GM, granulocyte-macrophage.
a) BSC was defined as having received first-line therapy but not continuing to second-line therapy,
b) Hospitalizations were classified as occurring in a particular line of therapy if there was overlap in the dates of hospitalization and the line of therapy. Hospitalizations for chemotherapy infusion that overlapped between first-line therapy and BSC were counted toward both lines of treatment.
Variable | No. (%) |
---|---|
MGC patient | 198 (100) |
Age at MGC diagnosis, mean±SD | 61.3±9.8 |
Age group at MGC diagnosis (yr) | |
25-44 | 12 (6.1) |
45-54 | 31 (15.7) |
55-64 | 73 (36.9) |
≥ 65 | 82 (41.4) |
Male | 146 (73.7) |
Body mass index |
21.4±2.6 |
Smoking history | |
Non-smoker | 83 (41.9) |
Current smoker | 38 (19.2) |
Former smoker | 55 (27.8) |
Unknown | 22 (11.1) |
Alcohol consumption | |
No alcohol use | 68 (34.3) |
Light to moderate | 94 (47.5) |
Heavy | 18 (9.1) |
Unknown | 18 (9.1) |
History of Helicobacter pylori infection | 8 (4.0) |
Family history of gastric cancer | 13 (6.6) |
Charlson comorbidity index (CCI) |
0.4±0.6 |
Common comorbidity | |
Chronic atrophic gastritis | 45 (22.7) |
Cardiovascular disease | 37 (18.7) |
Intestinal metaplasia | 28 (14.1) |
Diabetes without chronic complications | 24 (12.1) |
Chronic obstructive pulmonary disease |
16 (8.1) |
Peptic ulcer disease |
15 (7.6) |
Stage IV at MGC diagnosis | 193 (97.5) |
Disease classification at MGC diagnosis | |
Intestinal | 48 (24.2) |
Diffuse | 72 (36.4) |
Mixed | 13 (6.6) |
Unknown | 65 (32.8) |
Tumor location | |
Antrum and pylorus | 102 (51.5) |
Fundus and corpus | 48 (24.2) |
Gastric cardia | 25 (12.6) |
Esophagogastric junction | 11 (5.6) |
Whole stomach | 7 (3.5) |
Other | 1 (0.5) |
Unknown | 4 (2) |
Metastatic site | |
Peritoneum | 106 (53.5) |
Lymph nodes | 94 (47.5) |
Liver | 77 (38.9) |
Bone | 22 (11.1) |
Lung | 9 (4.5) |
Other | 9 (4.5) |
Tested for HER2/neu gene expression |
84 (42.4) |
HER2 positive | 8 (9.5) |
HER2 negative | 75 (89.3) |
HER2 status unknown | 1 (1.2) |
Variable | No. (%) |
---|---|
MGC patient | 198 (100) |
Patient who received first-line chemotherapy treatment | 198 (100) |
Patient who received second-line chemotherapy treatment | 159 (80.3) |
Patient who received third-line chemotherapy treatment | 46 (23.2) |
Patient who received BSC only after first-line | 39 (19.7) |
ECOG PS score of first-line patients |
|
0: Asymptomatic | 25 (12.6) |
1: Symptomatic but completely ambulatory | 151 (76.3) |
2: Symptomatic, < 50% in bed during the day | 19 (9.6) |
4: Bedbound | 2 (1.0) |
Unknown | 1 (0.5) |
First-line regimen |
|
Fluoropyrimidine+platinum (+/- leucovorin) | 120 (60.6) |
Capecitabine+platinum | 29 (14.6) |
Single-agent fluoropyrimidine (+/- leucovorin) | 38 (19.2) |
Reason for initiating second-line therapy | 159 (100) |
Tumor progression | 152 (95.6) |
Toxicity of first-line therapy | 7 (4.4) |
ECOG PS score of second-line patients |
159 (100) |
0: Asymptomatic | 16 (10.1) |
1: Symptomatic but completely ambulatory | 105 (66.0) |
2: Symptomatic, < 50% in bed during the day | 35 (22.0) |
Unknown | 3 (1.9) |
Second-line regimen |
159 (100) |
Single agent fluoropyrimidine (+/- leucovorin) | 35 (22.0) |
S-1 | 11 (6.9) |
Capecitabine | 9 (5.7) |
5-FU | 7 (4.4) |
Irinotecan+platinum and/or fluoropyrimidine (+/- leucovorin) | 31 (19.5) |
Irinotecan, 5-FU, leucovorin | 15 (9.4) |
Irinotecan, 5-FU | 10 (6.3) |
Fluoropyrimidine+platinum agent (+/- leucovorin) | 21 (13.2) |
Capecitabine+platinum agent | 9 (5.7) |
5-FU+platinum agent | 7 (4.4) |
S-1+platinum agent | 5 (3.1) |
Single-agent taxane | 13 (8.2) |
Docetaxel | 9 (5.7) |
Other |
59 (37.1) |
ECOG score of third-line patient | 46 (100) |
0: Asymptomatic | 5 (10.9) |
1: Symptomatic but completely ambulatory | 25 (54.3) |
2: Symptomatic, < 50% in bed during the day | 16 (34.8) |
Unknown | 0 |
Third-line regimen | |
Single-agent fluoropyrimidine (+/- leucovorin) | 12 (26.1) |
Fluoropyrimidine+platinum agent (+/- leucovorin) | 11 (23.9) |
Single-agent taxane | 9 (19.6) |
Irinotecan+platinum and/or fluoropyrimidine (+/- leucovorin) | 7 (15.2) |
Other | 7 (15.2) |
Variable | First-line followed by BSC (n=39) | First-line followed by second-line (n=159) | p-value |
---|---|---|---|
Age at MGC diagnosis (yr) | |||
Years | 64.5±9.3 | 60.5±9.8 | 0.012* |
Median (Q1-Q3) | 66 (60-71) | 62 (55-67) | |
Distribution (yr) | |||
25-34 | 1 (2.6) | 3 (1.9) | > 0.990 |
35-44 | 0 | 8 (5.0) | 0.360 |
45-54 | 5 (12.8) | 26 (16.4) | 0.587 |
55-64 | 11 (28.2) | 62 (39.0) | 0.211 |
≥ 65 | 22 (56.4) | 60 (37.7) | 0.034* |
Male | 31 (79.5) | 115 (72.3) | 0.363 |
Ethnicity | |||
East Asian | 39 (100) | 159 (100) | > 0.990 |
BMI (kg/m2) |
21.8±2.8 | 21.3±2.5 | 0.121 |
Smoking history | |||
Non-smoker | 18 (46.2) | 65 (40.9) | 0.550 |
Current smoker | 9 (23.1) | 29 (18.2) | 0.492 |
Former smoker | 11 (28.2) | 44 (27.7) | 0.947 |
Unknown | 1 (2.6) | 21 (13.2) | 0.084 |
Alcohol consumption | |||
No alcohol use | 11 (28.2) | 57 (35.8) | 0.368 |
Light to moderate | 19 (48.7) | 75 (47.2) | 0.862 |
Heavy | 6 (15.4) | 12 (7.5) | 0.131 |
Unknown | 3 (7.7) | 15 (9.4) | > 0.990 |
Performance status (ECOG score) |
|||
0: Asymptomatic | 1 (2.6) | 24 (15.1) | 0.033* |
1: Symptomatic but completely ambulatory | 31 (79.5) | 120 (75.5) | 0.597 |
2: Symptomatic, < 50% in bed during the day | 5 (12.8) | 14 (8.8) | 0.542 |
3: Symptomatic, > 50% in bed, but not bedbound | 0 | 0 | - |
4: Bedbound | 2 (5.1) | 0 | 0.038* |
Unknown | 0 | 1 (0.6) | > 0.990 |
Variable | First-line (n=198) | Second-line (n=159) | BSC, no second-line |
Third-line (n=46) |
---|---|---|---|---|
Supportive care | ||||
Antiemetics | 103 (52.0) | 71 (44.7) | 7 (17.9) | 21 (45.7) |
Analgesics | 74 (37.4) | 58 (36.5) | 9 (23.1) | 13 (28.3) |
Granulocyte-colony stimulating factors | 11 (5.6) | 13 (8.2) | 0 | 3 (6.5) |
Diuretics | 9 (4.5) | 6 (3.8) | 1 (2.6) | 1 (2.2) |
Antidepressants | 6 (3.0) | 4 (2.5) | 1 (2.6) | 0 |
Erythropoiesis stimulating agents | 4 (2.0) | 2 (1.3) | 0 | 0 |
GM-colony stimulating factors | 2 (1.0) | 0 | 0 | 0 |
Narcotics | 0 | 1 (0.6) | 0 | 0 |
Nutritional support | 27 (13.6) | 18 (11.3) | 4 (10.3) | 4 (8.7) |
Inpatient hospitalization | ||||
At least one stay | 71 (35.9) | 48 (30.2) | 13 (33.3) | 11 (23.9) |
No. of visits/patient | 3.5±3.4 | 2.1±1.4 | 2.5±2.5 | 3.7±2.0 |
Length of stay/hospitalization (day) | 8.2±9.4 | 9.1±11.3 | 14.3±15.6 | 10.2±12.5 |
Main reasons for visit | ||||
Chemotherapy infusion | 182 (73.4) | 68 (68.7) | 17 (53.1) |
23 (56.1) |
Disease symptom management | 38 (15.3) | 21 (21.2) | 9 (28.1) | 11 (26.8) |
Adverse events/toxicity | 19 (7.7) | 6 (6.1) | 2 (6.3) | 4 (9.8) |
Pain management | 2 (0.8) | 2 (2.0) | 3 (9.4) | 3 (7.3) |
Gastric cancer–related surgery | 6 (2.4) | 0 | 1 (3.1) | 0 |
Regular monitoring | 0 | 2 (2.0) | 0 | 0 |
Outpatient hospitalization (patients with information available) | 92 | 79 | 13 | 21 |
At least one visit | 59 (64.1) | 25 (31.6) | 4 (30.8) | 7 (33.3) |
Mean visits/patient | 3.2±4.3 | 2.5±3.3 | 1±0.0 | 2.7±2.5 |
Hospice unit (patients with information available) | 34 | 29 | 5 | 10 |
At least one stay | 1 (2.9) | 0 | 1 (20) | 2 (20.0) |
Oncologist clinic (patients with information available) | 127 | 102 | 25 | 28 |
At least one visit | 86 (67.7) | 60 (58.8) | 9 (36) | 10 (35.7) |
No. of visits/patient | 3.9±3.3 | 3.0±3.6 | 5.1±5.2 | 2.8±1.9 |
MGC, metastatic and/or locally recurrent, unresectable gastric cancer; SD, standard deviation; HER2, human epidermal growth factor receptor 2. Patients with weight less than 20 kg (n=1) were assumed to have the population average weight of 58 kg, The CCI was calculated excluding any malignancy (including leukemia and lymphoma) and metastatic solid tumor, Comorbidities contributing to the CCI are marked, The proportions of patients with positive, negative, and unknown values for HER2/neu gene expression are only among the tested patients.
MGC, metastatic and/or locally recurrent, unresectable gastric cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; 5-FU, 5-fluorouracil. Karnofsky scores were converted to ECOG PS scores (100 [ECOG PS 0], 80-90 [ECOG PS 1], 60-70 [ECOG PS 2], 40-50 [ECOG PS 3], and 10-30 [ECOG PS 4]), A patient could have received a maximum of four therapeutic agents, Other regimens included: irinotecan or oxaliplatin (6.9%), leucovorin/irinotecan (6.3%), cisplatin (5.7%), cisplatin/docetaxel (3.1%), and various other agents received by fewer than 2% of patients.
Values are presented as mean±standard deviation or number (%) unless otherwise indicated. BSC, best supportive care; MGC, metastatic and/or locally recurrent, unresectable gastric cancer; BMI, body mass index; ECOG, Eastern Cooperative Oncology Group. Chi-squared or Fisher exact tests for categorical variables, Wilcoxon rank sum tests for continuous variables. p-values of < 0.05 are indicated by an asterisk (*), Patients weighing less than 20 kg (n=1) were assumed to have a population average weight of 58 kg, Performance status was assessed at the beginning of first-line treatment.
Values are presented as number (%) or mean±standard deviation unless otherwise indicated. BSC, best supportive care; GM, granulocyte-macrophage. BSC was defined as having received first-line therapy but not continuing to second-line therapy, Hospitalizations were classified as occurring in a particular line of therapy if there was overlap in the dates of hospitalization and the line of therapy. Hospitalizations for chemotherapy infusion that overlapped between first-line therapy and BSC were counted toward both lines of treatment.