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J. Crawford
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MINI 37 - SCLC Therapy (ID 165)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:D. Ettinger, G.R. Simon
- Coordinates: 9/09/2015, 18:30 - 20:00, 605+607
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MINI37.07 - PCI Survival Improvement for Extensive Stage SCLC Limited to Patients on Maintenance Systemic Therapy: A Secondary Analysis of CALGB 30504 (ID 861)
18:30 - 20:00 | Author(s): J. Crawford
- Abstract
- Presentation
Background:
PCI has become standard of care for extensive stage small cell lung cancer (ES-SCLC) patients. However, one recent randomized study establishing this standard did not require brain imaging prior to enrollment, and another, which did, failed to show a benefit for PCI. CALGB 30504 (Alliance) was a randomized phase II study of sunitinib vs placebo in ES-SCLC patients responding to at least 4 cycles of platinum based therapy requiring baseline brain imaging at enrollment. As this study spanned the introduction of PCI for ES-SCLC, PCI was left to the discretion of the treating team. Therefore, we performed a secondary analysis of CALGB 30504 to determine the impact of PCI on ES-SCLC patients.
Methods:
CALGB 30504 was a phase II randomized study in ES-SCLC comparing maintenance sunitinib versus placebo following SD or CR/PR to 4-6 cycles of etopside 100 mg/m[2] d1-3 and either carboplatin AUC=5 or cisplatin 80 mg/m[2] d1 q 21 days. Sunitinib was 150 mg PO d 1 then 37.5 mg PO qd until progression. The primary objective was to determine if maintenance sunitinib would improve PFS, as was recently reported. PCI was recommended at 25 Gy in 2.5 Gy fractions, within 4-6 weeks of chemotherapy, but not required. Sunitinib was to be held 2 days prior, during, and 2 days after the completion of PCI. All statistical analyses were performed by the statisticians at Alliance/CALGB Statistical and Data Center on the platform of SAS (version 9.3; SAS Institution Inc., Cary, North Carolina).
Results:
85 patients received maintenance therapy(41placebo, 44 sunitinib). 41 (48%) received PCI, 44 didn’t. All patients and tumor characteristics were balanced between PCI and no-PCI patients. PCI dose was 25 Gy for 31 patients (range: 25-37.5 Gy). Median time to PCI was 21 wks (range: 12-27 wks) from enrollment. For all patients, PCI was associated with an improvement in PFS (median 7.8 vs 6.5 mo HR=0.63 (95% CI: 0.41-0.98), p=0.037), but not OS (median 12.9 vs 13.2 mo, HR=1.01 (95% CI: 0.64-1.62), p=0.955). In placebo patients, there was no PFS or OS difference between patients receiving PCI or not. In patients randomized to sunitinib, PCI conferred a PFS benefit (9.7 vs 6.8 mo, HR=0.49 (95% CI: 0.26-0.92), p=0.024), but not an OS benefit (14.1 vs 13.5 mo, HR=0.85 (95% CI: 0.44-1.66), p=0.636). When restricted to patients who did not receive PCI, there was no difference in survival between sunitinib or placebo patients. In PCI patients, those receiving sunitinib had non-significant improvement in PFS (9.7 vs 6.7 months, HR=0.63 (95% CI: 0.34-1.20), p=0.158) and trended towards an improvement in OS (14.1 vs 10.6 months, HR=0.56 (95% CI: 0.29-1.10), p=0.087), which was magnified and approached significance when crossover patients were excluded (14.1 vs 10.0 mo, HR=0.49 (95% CI: 0.22-1.06), p=0.064).
Conclusion:
PFS, and trends for OS improvement were limited to patients receiving the combination of PCI and maintenance sunitinib. Placebo patients did not benefit from PCI. Improved outcomes for ES-SCLC patients with PCI are likely limited to patients who achieve both intracranial and extracranial disease control.
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P3.11 - Poster Session/ Palliative and Supportive Care (ID 231)
- Event: WCLC 2015
- Type: Poster
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.11-006 - An Analysis of Factors Associated with in Hospital Mortality in Lung Cancer Chemotherapy Patients with Neutropenia (ID 1252)
09:30 - 17:00 | Author(s): J. Crawford
- Abstract
Background:
Febrile neutropenia is considered a severe complication of cancer chemotherapy, and one for which lung cancer is frequently associated with higher mortality rates than other solid tumors. The focus of this analysis was to identify risk factors most associated with in-hospital mortality and to describe their impact on mortality in patients with lung cancer.
Methods:
Hospitalization data from the University Health Consortium database inclusive of the years 2004-2012 from 239 US medical centers were analyzed. The study population included all adult patients with solid tumors who had neutropenia. Cancer type, presence of neutropenia, comorbidities, and further subgroups were based on ICD-9-CM codes. The primary study outcome was in-hospital mortality in lung cancer patients vs. other solid tumors. Further analysis concentrated on comparisons of the two groups with respect to number and type of comorbidities, occurrence of sepsis, pneumonia, or any infection, and ICU stay and influence of these factors on mortality. Differences between the groups were compared using chi-square test.
Results:
The analysis was based on 61,086 adult patients, including 11,111 lung cancer patients and 49,975 patients with other solid tumors. Overall 4290 (7.0%) patients died. Lung cancer was the tumor type associated with highest mortality (11.2%, compared with other solid tumors, 6.1%; p <0.0001) Lung cancer patients were older: 50% of lung cancer patients were over age 65, compared to 31.6% of patients with other solid tumors (p<0.0001). Lung cancer patients were more likely to have multiple (≥2) comorbidities than patients with other solid tumors (57.3% vs. 37.3% p<0.0001). The risk of mortality was directly related to the number of comorbidities (ranging from mortality risk of 0.9% for patients with 0 comorbidities to 35.2% for patients with 5 or more). The comorbidity-mortality relationship was observed in lung cancer patients as well as patients with other solid tumors, and the association persisted after adjusting for multiple covariates, including age. Even independent of number of comorbidities and age, lung cancer patients had higher mortality (Odds Ratio (OR)=1.38, 95%CI: 1.28-1.48). Four risk factors for mortality in addition to number of comorbidities were identified: pneumonia, sepsis, any documented infection, and ICU stay. Pneumonia occurred more commonly in the lung cancer patients (26.4% vs. 10.3%; p<0.0001). Comorbid pulmonary disease was strongly associated with development of pneumonia (OR=4.52, 95%CI: 4.30-4.74) and occurred more often in the lung cancer patients (52.1% vs. 24.0%; p<0.0001). With or without pulmonary disease as a comorbidity, lung cancer patients were more likely to have pneumonia than other solid tumor types (with – 36.0% vs. 22.8%, p<0.0001) (without – 16.1% vs. 6.4%, p<0.0001).
Conclusion:
Lung cancer patients presenting with febrile neutropenia are older, have more comorbidities, have a higher incidence of comorbid pulmonary disease, and are more likely to have pneumonia. These factors may help explain their higher mortality. In order to reduce the mortality of chemotherapy in lung cancer patients, careful pretreatment assessment and optimal supportive care during therapy are critical.
