In the United States (US), soft tissue sarcoma (STS) is considered a relatively rare cancer, accounting for fewer than 1% of all malignancies [
For patients with advanced, unresectable or metastatic non-GIST STS, systemic chemotherapy, particularly containing anthracyclines, has been the standard of care for several decades [
The National Comprehensive Cancer Network (NCCN) guidelines (4.2019) recommend over 20 different regimens for the treatment of STS with nonspecific histologies [
A high degree of treatment heterogeneity has been observed in the previous observational research of patients diagnosed with STS in the US. Based on a medical record review of 99 patients with metastatic or relapsed STS treated in a tertiary academic cancer care center between 2001 and 2011, most patients received anthracycline- or gemcitabine-based regimens, but there was not a predominant treatment in any line of therapy [
Olaratumab is a monoclonal antibody that selectively binds platelet-derived growth factor receptor alpha and blocks ligand binding [
The clinical benefit of olaratumab and doxorubicin, however, was not confirmed in the subsequent phase III ANNOUCE trial [
This study was designed to describe current clinical and demographic characteristics, treatment patterns, and healthcare resource utilization (HCRU) among patients diagnosed with advanced or metastatic STS in a US community-based network of oncology practices. These factors were compared among the cohorts treated prior to and following the October 2016 FDA-accelerated approval of olaratumab.
A retrospective observational cohort study was conducted of adult patients newly diagnosed with advanced or metastatic STS within the US Oncology Network (USON). The USON is a network of more than 450 community-based oncology clinics across the US [
Both structured and unstructured variables from the USON’s electronic health record (EHR) and targeted chart review were used to build the study database. The EHR of the USON, iKnowMed (iKM), captures outpatient practice encounter histories for patients under community-based care, including but not limited to: patient demographics such as age and gender; clinical information such as disease diagnosis, diagnosis stages, performance status information, and laboratory testing results; and treatment information, such as line of therapy and treatment administrations within the USON. The claims and remittance database of the USON was used to assess HCRU of services provided within the USON.
A targeted chart review was performed to capture information on key variables that were anticipated to be poorly documented in the structured EHR fields. This included capture of some data only available in unstructured fields, including information on hospitalizations and emergency department (ED) visits that occurred during the study observation period, as well as histological subtypes and tumor location. Chart review was accomplished by use of a secure, web-based electronic case report form and conducted by trained oncology professionals. These chart reviewers captured information as it was explicitly documented in the medical record; central pathology review was not undertaken to verify what physicians recorded in the patient record. The chart review was conducted for a subset of eligible patients who initiated first-line treatment between 01 July 2015 and 31 August 2017.
Eligible patients were at least 18 years of age with a documented diagnosis of STS and who initiated first-line treatment between 01 July 2015 and 31 August 2018. Additionally, patients were required to have at least two follow-up visits within the USON after first-line treatment initiation at clinics that had fully implemented the EHR system, iKM. Patients enrolled in clinical trials or who were diagnosed with another primary cancer were excluded from the analysis. Additional exclusion criteria included the following: diagnosis of Ewing’s sarcoma, osteosarcoma or Kaposi’s sarcoma, and receipt of treatments suggestive of clinical trial participation or nonsarcoma diagnosis (i.e., thalidomide, rituximab, afatinib, binimetinib, dabrafenib, regorafenib, and ribociclib).
Patients were followed from initiation of first-line treatment until the end of the study period (31 August 2018) or last USON visit date. All study variables and outcomes were assessed regardless of maximum follow-up using data available until the end of the study period. Baseline variables were assessed for the 60-day period prior to and up to 30 days after first-line treatment initiation. Patients were categorized in the pre-October 2016 cohort if they initiated first-line treatment between 01 July 2015 and 18 October 2016, and in the post-October 2016 cohort if they initiated treatment between 19 October 2016 and 31 August 2018. If a patient was included in the pre-October 2016 cohort but advanced to second-line treatment after 19 October 2016, they remained classified in the pre-October 2016 cohort.
Descriptive statistics were used to examine demographic, clinical, and treatment characteristics for patients in the first- and second-line settings. Categorical variables (e.g., gender and performance status) were reported as frequencies and percentages. Continuous variables such as age were reported as mean, standard deviation, median, and range. In the case of missing observations, the number and percentage of missing values were reported. Programmatic logic was applied to categorize therapy sequences across lines of therapy based on start and stop dates, as well as the predefined line of therapy indicator in iKM.
Chi-squared or Fisher’s exact test was used to assess differences between categories of variables when at least 5 patients were represented in each group.
In total, 376 patients met eligibility criteria and were included in the analysis; 211 of these patients were selected for chart review, while the remaining 165 patients contributed to structured data only. Among the overall study population, 97 patients initiated first-line treatment in the pre-October 2016 period and 279 in the post-October 2016 period (prior to and after accelerated approval of olaratumab; Table
Baseline demographic and clinical characteristics overall and for the pre- and post-2016 cohorts.
Overall ( |
1L pre-October 2016 cohort ( |
1L post-October 2016 cohort ( |
|
Overall ( |
2L pre-October 2016 cohort ( |
2L post-October 2016 cohort ( |
| |
---|---|---|---|---|---|---|---|---|
Median age at 1L initiation |
62 (20, 90+) | 62 (25, 84) | 62 (20, 90+) | 0.9460 | 60 (21, 86) | 60 (30, 82) | 61 (21, 86) | 0.8195 |
|
182 (48.4) | 50 (51.5) | 132 (47.3) | 0.4722 | 90 (45.9) | 38 (49.4) | 52 (43.7) | 0.4380 |
|
0.8902 | 0.8028 | ||||||
Caucasian | 28 (76.3) | 74 (76.3) | 213 (76.3) | 144 (73.5) | 56 (72.7) | 88 (74.0) | ||
Black or African American | 27 (7.2) | 6 (6.2) | 21 (7.5) | 16 (8.2) | 6 (7.8) | 10 (8.4) | ||
Others | 15 (4.0) | 5 (5.2) | 10 (3.6) | 9 (4.6) | 5 (6.5) | 4 (3.4) | ||
No information | 47 (12.5) | 12 (12.4) | 35 (12.5) | — | 27 (13.8) | 10 (13.0) | 17 (14.3) | — |
|
0.7285 | 0.8281 | ||||||
Underweight (BMI < 18.5) | 9 (2.4) | 1 (1.0) | 8 (2.9) | 5 (2.6) | 1 (1.3) | 4 (3.4) | ||
Normal (BMI: 18.5 - < 25) | 104 (27.7) | 27 (27.8) | 77 (27.6) | 50 (25.5) | 20 (26.0) | 30 (25.2) | ||
Overweight (BMI: 25– < 30) | 116 (30.9) | 33 (34.0) | 83 (29.7) | 56 (28.6) | 24 (31.2) | 32 (26.9) | ||
Obese (BMI = 30+) | 147 (39.1) | 36 (37.1) | 111 (39.8) | 85 (43.4) | 32 (41.6) | 53 (44.5) | ||
|
0.8993 | 0.8161 | ||||||
0 | 62 (16.5) | 17 (17.5) | 45 (16.1) | 38 (19.4) | 15 (19.5) | 23 (19.3) | ||
1 | 221 (58.8) | 57 (58.8) | 164 (58.8) | 116 (59.2) | 45 (58.4) | 71 (59.7) | ||
2 | 39 (10.4) | 8 (8.2) | 31 (11.1) | 13 (6.6) | 7 (9.1) | 6 (5.0) | ||
3 | 2 (0.5) | 0 (0.00) | 2 (0.7) | 1 (0.5) | 0 (0.00) | 1 (0.8) | ||
No information | 52 (13.8) | 15 (15.5) | 37 (13.3) | — | 28 (14.3) | 10 (13.0) | 18 (15.1) | — |
|
0.6024 | 0.3299 | ||||||
Sarcoma | 213 (56.6) | 56 (57.7) | 157 (56.3) | 107 (54.6) | 41 (53.2) | 66 (55.5) | ||
Leiomyosarcoma | 83 (22.1) | 25 (25.8) | 58 (20.8) | 45 (23.0) | 23 (29.9) | 22 (18.5) | ||
Uterine sarcoma | 52 (13.8) | 12 (12.4) | 40 (14.3) | 30 (15.3) | 10 (13.0) | 20 (16.8) | ||
Fibrosarcoma | 14 (3.7) | 1 (1.0) | 13 (4.7) | 8 (4.1) | 1 (1.3) | 7 (5.9) | ||
Chondrosarcoma | 8 (2.1) | 2 (2.1) | 6 (2.2) | 3 (1.5) | 1 (1.3) | 2 (1.7) | ||
Rhabdomyosarcoma | 6 (1.6) | 1 (1.0) | 5 (1.8) | 3 (1.5) | 1 (1.3) | 2 (1.7) | ||
|
0.1641 | 0.1871 | ||||||
Angiosarcoma | 11 (2.9) | 8 (8.2) | 3 (1.1) | 7 (3.6) | 6 (7.8) | 1 (0.8) | ||
Fibroblastic/myofibroblastic | 10 (2.7) | 2 (2.1) | 8 (2.9) | 7 (3.6) | 2 (2.6) | 5 (4.2) | ||
Leiomyosarcoma | 87 (23.1) | 40 (41.2) | 47 (16.8) | 62 (31.6) | 35 (45.5) | 27 (22.7) | ||
Liposarcoma | 16 (4.3) | 4 (4.1) | 12 (4.3) | 9 (4.6) | 3 (3.9) | 6 (5.0) | ||
Nerve sheath sarcoma | 4 (1.1) | 2 (2.1) | 2 (0.7) | 1 (0.5) | 0 (0.00) | 1 (0.8) | ||
Others | 25 (6.6) | 7 (7.2) | 18 (6.5) | 15 (7.7) | 4 (5.2) | 11 (9.2) | ||
Rhabdomyosarcoma | 10 (2.7) | 5 (5.2) | 5 (1.8) | 7 (3.6) | 4 (5.2) | 3 (2.5) | ||
Synovial | 8 (2.1) | 4 (4.1) | 4 (1.4) | 6 (3.1) | 3 (3.9) | 3 (2.5) | ||
Undifferentiated pleomorphic sarcoma | 36 (9.6) | 19 (19.6) | 17 (6.1) | 24 (12.2) | 14 (18.2) | 10 (8.4) | ||
Documented unknown | 4 (1.1) | 2 (2.1) | 2 (0.7) | — | 3 (1.5) | 2 (2.6) | 1 (0.8) | — |
No information | 165 (43.9) | 4 (4.1) | 161 (57.7) | — | 55 (28.1) | 4 (5.2) | 51 (42.9) | — |
|
0.5625 | 0.8542 | ||||||
Axilla | 1 (0.3) | 1 (1.0) | 0 (0.00) | 1 (0.5) | 1 (1.3) | 0 (0.00) | ||
Breast | 2 (0.5) | 2 (2.1) | 0 (0.00) | 2 (1.0) | 2 (2.6) | 0 (0.00) | ||
Genitourinary | 5 (1.3) | 2 (2.1) | 3 (1.1) | 5 (2.6) | 2 (2.6) | 3 (2.5) | ||
Head or neck | 8 (2.1) | 5 (5.2) | 3 (1.1) | 4 (2.0) | 3 (3.9) | 1 (0.8) | ||
Lower limb | 47 (12.5) | 24 (24.7) | 23 (8.2) | 33 (16.8) | 18 (23.4) | 15 (12.6) | ||
Mediastinum, lung, pleura | 5 (1.3) | 3 (3.1) | 2 (0.7) | 4 (2.0) | 3 (3.9) | 1 (0.8) | ||
Others | 44 (11.7) | 19 (19.6) | 25 (9.0) | 29 (14.8) | 13 (16.9) | 16 (13.4) | ||
Pelvis | 5 (1.3) | 2 (2.1) | 3 (1.1) | 4 (2.0) | 2 (2.6) | 2 (1.7) | ||
Retroperitoneal | 20 (5.3) | 8 (8.2) | 12 (4.3) | 11 (5.6) | 7 (9.1) | 4 (3.4) | ||
Trunk | 10 (2.7) | 4 (4.1) | 6 (2.2) | 6 (3.1) | 3 (3.9) | 3 (2.5) | ||
Upper limb | 16 (4.3) | 5 (5.2) | 11 (3.9) | 10 (5.1) | 4 (5.2) | 6 (5.0) | ||
Uterus | 45 (12.0) | 16 (16.5) | 29 (10.4) | 29 (14.8) | 13 (16.9) | 16 (13.4) | ||
Documented unknown | 3 (0.8) | 2 (2.1) | 1 (0.4) | — | 3 (1.5) | 2 (2.6) | 1 (0.8) | — |
No information | 165 (43.9) | 4 (4.1) | 161 (57.7) | — | 55 (28.1) | 4 (5.2) | 51 (42.9) | — |
|
0.5287 | 0.4477 | ||||||
Well differentiated | 17 (4.5) | 4 (4.1) | 13 (4.7) | 6 (3.1) | 2 (2.6) | 4 (3.4) | ||
Moderately differentiated | 47 (12.5) | 15 (15.5) | 32 (11.5) | 27 (13.8) | 13 (16.9) | 14 (11.8) | ||
Poorly differentiated | 158 (42.0) | 45 (46.4) | 113 (40.5) | 83 (42.3) | 36 (46.8) | 47 (39.5) | ||
Undifferentiated | 5 (1.3) | 1 (1.0) | 4 (1.4) | 2 (1.0) | 0 (0.00) | 2 (1.7) | ||
No information | 149 (39.6) | 32 (33.0) | 117 (41.9) | — | 78 (39.8) | 26 (33.8) | 52 (43.7) | — |
|
<0.0001 | 0.3188 | ||||||
0 | 137 (36.4) | 16 (16.5) | 121 (43.4) | 54 (27.6) | 16 (20.8) | 38 (31.9) | ||
1 | 127 (33.8) | 40 (41.2) | 87 (31.2) | 73 (37.2) | 28 (36.4) | 45 (37.8) | ||
2 | 71 (18.9) | 24 (24.7) | 47 (16.8) | 46 (23.5) | 20 (26.0) | 26 (21.8) | ||
3 | 29 (7.7) | 11 (11.3) | 18 (6.5) | 15 (7.7) | 8 (10.4) | 7 (5.9) | ||
4 | 7 (1.9) | 3 (3.1) | 4 (1.4) | 3 (1.5) | 2 (2.6) | 1 (0.8) | ||
5 | 5 (1.3) | 3 (3.1) | 2 (0.7) | 5 (2.6) | 3 (3.9) | 2 (1.7) | ||
|
46 (12.2) | 18 (18.6) | 28 (10.0) | 0.0274 | 28 (14.3) | 14 (18.2) | 14 (11.8) | 0.2099 |
|
4 (1.1) | 1 (1.0) | 3 (1.1) | 1.0000 | 2 (1.0) | 1 (1.3) | 1 (0.8) | 1.0000 |
|
3 (0.8) | 0 (0.00) | 3 (1.1) | 0.5720 | 1 (0.5) | 0 (0.00) | 1 (0.8) | 1.0000 |
|
3 (0.8) | 1 (1.0) | 2 (0.7) | 1.0000 | 1 (0.5) | 1 (1.3) | 0 (0.00) | 0.3929 |
|
37 (9.8) | 17 (17.5) | 20 (7.2) | 0.0032 | 20 (10.2) | 10 (13.0) | 10 (8.4) | 0.3005 |
|
18 (4.8) | 7 (7.2) | 11 (3.9) | 0.1933 | 12 (6.1) | 5 (6.5) | 7 (5.9) | 0.8616 |
|
47 (12.5) | 16 (16.5) | 31 (11.1) | 0.1673 | 30 (15.3) | 14 (18.2) | 16 (13.4) | 0.3684 |
|
149 (39.6) | 54 (55.7) | 95 (34.1) | 0.0002 | 89 (45.4) | 43 (55.8) | 46 (38.7) | 0.0183 |
|
8 (2.1) | 3 (3.1) | 5 (1.8) | 0.4303 | 4 (2.0) | 3 (3.9) | 1 (0.8) | 0.3019 |
|
94 (25.0) | 31 (32.0) | 63 (22.6) | 0.0661 | 60 (30.6) | 24 (31.2) | 36 (30.3) | 0.8918 |
1L, first-line; 2L, second-line; BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; Min, minimum; Max, maximum; SD, standard deviation.
The median duration of follow-up across the study population was 7.3 months (range 0.0, 79.6; data not shown). Patients who initiated first-line treatment during the pre-October 2016 period had a median duration of follow-up of 12.5 months (range 0.0, 79.6) compared with a median duration of 5.6 months (range 0.0, 22.8) among patients who initiated first-line treatment during the post-October 2016 period.
Baseline demographic and clinical characteristics of patients who initiated first-line treatment and those who received second-line treatment are presented in Table
Tumor histology and location were not documented in structured fields of the EHR and, as such, were only captured for patients selected for chart review (Table
Among the 196 patients who received second-line treatment, at initiation of first-line treatment the median age was 60 years (range 21, 86), with 45.9% male and 73.5% Caucasian (Table
Overall, demographic and clinical characteristics were similar between patients in the pre- and post-October 2016 cohorts (Table
Table
Treatment regimens in the pre- and post-2016 periods.
Overall ( |
1L pre-October 2016 cohort ( |
1L post-October 2016 cohort ( | |
---|---|---|---|
|
|||
Gemcitabine + docetaxel | 125 (33.2) | 44 (45.4) | 81 (29.0) |
Olaratumab + doxorubicin | 64 (17.0) | 0 (0.0) | 64 (22.9) |
Gemcitabine | 27 (7.2) | 5 (5.2) | 22 (7.9) |
Doxorubicin + ifosfamide | 25 (6.6) | 7 (7.2) | 18 (6.5) |
Doxorubicin | 24 (6.4) | 13 (13.4) | 11 (3.9) |
Pazopanib | 18 (4.8) | 5 (5.2) | 13 (4.7) |
Dacarbazine + doxorubicin | 16 (4.3) | 3 (3.1) | 13 (4.7) |
Liposomal doxorubicin | 12 (3.2) | 7 (7.2) | 5 (1.8) |
Paclitaxel | 10 (2.7) | 3 (3.1) | 7 (2.5) |
Cyclophosphamide + dactinomycin + vincristine | 5 (1.3) | 2 (2.1) | 3 (1.1) |
Other 1L regimen |
50 (13.3) | 8 (8.2) | 42 (14.1) |
|
|||
No 2L treatment observed | 180 (47.9) | 20 (20.6) | 160 (57.3) |
Gemcitabine + docetaxel | 49 (13.0) | 11 (11.3) | 38 (13.6) |
Pazopanib | 24 (6.4) | 13 (13.4) | 11 (3.9) |
Olaratumab + doxorubicin | 23 (6.1) | 5 (5.2) | 18 (6.5) |
Trabectedin | 15 (4.0) | 7 (7.2) | 8 (2.9) |
Doxorubicin | 11 (2.9) | 8 (8.2) | 3 (1.1) |
Gemcitabine | 10 (2.7) | 1 (1.0) | 9 (3.2) |
Eribulin mesylate | 7 (1.9) | 2 (2.1) | 5 (1.8) |
Olaratumab | 6 (1.6) | 2 (2.1) | 4 (1.4) |
Pembrolizumab | 6 (1.6) | 3 (3.1) | 3 (1.1) |
Doxorubicin + ifosfamide | 5 (1.3) | 4 (4.1) | 1 (0.4) |
Other 2L regimen |
40 (10.6) | 21 (21.6) | 19 (6.8) |
|
|||
No 3L treatment observed | 291 (77.4) | 56 (57.7) | 235 (84.2) |
Olaratumab + doxorubicin | 17 (4.5) | 7 (7.2) | 10 (3.6) |
Trabectedin | 15 (4.0) | 9 (9.3) | 6 (2.2) |
Pazopanib | 7 (1.9) | 3 (3.1) | 4 (1.4) |
Gemcitabine + docetaxel | 6 (1.6) | 2 (2.1) | 4 (1.4) |
Other 3L regimen |
40 (10.6) | 20 (20.6) | 20 (7.2) |
|
|||
Gemcitabine + docetaxel > none | 60 (16.0) | 9 (9.3) | 51 (18.3) |
Gemcitabine + docetaxel > olaratumab + doxorubicin | 19 (5.1) | 5 (5.2) | 14 (5.0) |
Gemcitabine + docetaxel > pazopanib | 11 (2.9) | 7 (7.2) | 4 (1.4) |
Gemcitabine + docetaxel > doxorubicin | 8 (2.1) | 6 (6.2) | 2 (0.7) |
Gemcitabine + docetaxel > trabectedin | 8 (2.1) | 4 (4.1) | 4 (1.4) |
Other 1L to 2L treatment sequence† | 270 (71.8) | 66 (68.0) | 204 (73.1) |
1L, first-line; 2L, second-line 3L, third-line.
During the pre-October 2016 period, 45.4% (
In total, 180 patients (47.9%) did not receive second-line treatment and 291 (77.4%) did not receive third-line treatment during the study period within the USON (Table
During the post-October 2016 period, 111 patients in the study dataset received olaratumab either alone or in combination with other agents in the first- through third-line treatment settings. A small proportion of patients (6.5%) who initiated first-line treatment in the pre-October 2016 period proceeded to receive second-line olaratumab + doxorubicin during the post-October 2016 period (Figure
First- and second-line treatment regimens in the pre- and post-October 2016 periods received by at least 5 patients.
Among patients who initiated first-line treatment in the post-October 2016 period, 22.9% and 15.1% received olaratumab + doxorubicin in the first- and second-line setting, respectively (Figure
Among the 211 patients who underwent a chart review, hospitalizations were documented for 116 (55.0%), ED visits for 83 (39.3%) and surgeries for 42 (19.9%; Table
HCRU during the study period (chart review only).
Variable | Overall ( |
1L pre-October 2016 cohort ( |
1L post-October 2016 cohort ( |
|
Overall ( |
2L pre-October 2016 cohort ( |
2L post-October 2016 cohort ( |
|
---|---|---|---|---|---|---|---|---|
Patients hospitalized during the study period |
116 (30.9%) | 57 (58.8%) | 59 (21.1%) | <0.0001 | 82 (41.8%) | 46 (59.7%) | 36 (30.3%) | <0.0001 |
Patients with ED visits during the study period |
83 (22.1%) | 44 (45.4%) | 39 (14.0%) | <0.0001 | 60 (30.6%) | 36 (46.8%) | 24 (20.2%) | <0.0001 |
Patients with surgeries during the study period |
42 (11.2%) | 22 (22.7%) | 20 (7.2%) | <0.0001 | 32 (16.3%) | 20 (26.0%) | 12 (10.1%) | 0.0033 |
Patients with outpatient visits during the study period, |
297 (79.0%) | 83 (85.6%) | 214 (76.7%) | 0.0649 | 169 (86.2%) | 70 (90.9%) | 99 (83.2%) | 0.1258 |
Patients with laboratory procedures during the study period, |
266 (70.7%) | 75 (77.3%) | 191 (68.5%) | 0.0985 | 154 (78.6%) | 65 (84.4%) | 89 (74.8%) | 0.1087 |
Patients who received growth factors, | ||||||||
G-CSF | 143 (38.0%) | 70 (72.2%) | 73 (26.2%) | <0.0001 | 102 (52.0%) | 57 (74.0%) | 45 (37.8%) | <0.0001 |
ESA | 18 (4.8%) | 8 (8.2%) | 10 (3.6%) | 0.0639 | 16 (8.2%) | 8 (10.4%) | 8 (6.7%) | 0.3598 |
Patients who received dexrazoxane, |
13 (3.5%) | 2 (2.1%) | 11 (3.9%) | 0.5280 | 9 (4.6%) | 2 (2.6%) | 7 (5.9%) | 0.4869 |
Patients in the pre-October 2016 cohort had similar utilization of outpatient visits and laboratory procedures compared with those in the post-October 2016 cohort (Table
The results of this study provide insight into the patient characteristics and treatment patterns of patients diagnosed with advanced or metastatic STS receiving care in a US community-based practice setting before and shortly after the time of the accelerated approval of olaratumab on 19 October 2016. At initiation of first-line treatment, the baseline characteristics of the study population were similar to those observed in other real-world studies [
As observed in previously published observational studies of patients with advanced or metastatic STS, a high degree of treatment heterogeneity was observed across lines of therapy in this study [
During the approximate 2-year period following the accelerated approval of olaratumab, 111 patients (29.5%) received olaratumab in the first-, second- or third-line settings. Among patients who initiated first-line treatment during the pre-October 2016 period, 45% received first-line gemcitabine + docetaxel. During the post-October 2016 period, first-line use of gemcitabine + docetaxel was 29% and 23% received olaratumab + doxorubicin. These findings suggest that olaratumab was being utilized in community-based practice settings for the care of patients with advanced or metastatic STS. Given the limited follow-up period subsequent to olaratumab approval, the data were not mature enough to support survival analyses. Sufficient data were not available to examine the shift in treatment patterns following the results of the phase III study.
The GeDDiS trial was published during the observation period of this study and may have influenced the lower use of first-line gemcitabine + docetaxel in the post-October 2016 period [
Approximately 50% of patients did not receive second-line treatment in the USON database; however, this could in part be due to limited follow-up on the study population. The analyses did not account for patients who had recently discontinued first-line therapy, were still receiving first-line therapy at the end of the database, or who sought additional treatment outside of the USON. With similar limitations, approximately 60% of those treated in the second-line setting did not receive third-line therapy in the database.
Compared with patients who initiated first-line treatment prior to the October 2016 approval of olaratumab, those who initiated treatment in the post-October 2016 period had fewer observed hospitalizations, ED visits, and surgeries documented in the EHR (
Data for this study were sourced from the USON’s EHR database, which contains information documented during the course of routine patient care and was not collected for research purposes. Consequently, data entry errors and incomplete records could neither be verified nor corrected. Certain variables of interest were inconsistently documented. To enhance the study dataset, a chart review was performed to capture information that was not well-represented in the structured fields of the EHR, including histology and tumor location, for a subset of the study population. Likewise, information for services performed outside of the USON, such as hospitalizations and ED visits, was restricted to records and progress notes and could only be captured for patients undergoing chart review. By sourcing data solely from USON that utilized the full EHR capacities of iKM, the generalizability of this study may also be limited, and the cohort cannot be generalized to the overall US population.
This real-world retrospective study of patients with advanced or metastatic STS treated in a large community-based oncology network provides data regarding patient characteristics and treatment patterns outside of a clinical trial setting. The demographic and clinical data observed were consistent with those of the previous studies. The treatment pattern data suggest a dynamic treatment landscape that changed following the accelerated approval of olaratumab. Despite the increased utilization of olaratumab plus doxorubicin during the study period, considerable heterogeneity in treatment regimens was observed across the lines of therapy, suggesting the need for more evidence-based decision support to facilitate the care of the patient with STS.
The health data used to support the findings of this study are restricted by the US Oncology Institutional Review Board in order to protect patient privacy. For this reason, data used to support the findings of this study have not been made available.
Dr. Nadler, Ms. Aguilar, Dr. Wentworth, Mr. Boyd, Dr. Amirian, and Dr. Wilson were employees of McKesson Life Sciences, which received research funding from Eli Lilly and Co for conducting this study. Dr. Hess, Mr. Barker, and Ms. French were employed by Eli Lilly and Co during the study.
Dr. Lisa Kaspin-Powell provided editorial assistance for revision of this manuscript. This work was supported by Eli Lilly and Co. Employees of Eli Lilly and Co. collaborated in the study design, interpretation of data, writing, editing, co-authorship, and review of the manuscript for publication.