Outcomes of Patients with Advanced Non-Small Cell Lung Cancer Treated in a Phase I Clinic

Janků, Filip; Tsimberidou, Apostolia M.; Wang, Xuemei; Hong, David S.; Naing, Aung; Gong, Jing; Parsons, Henrique A.; Zinner, Ralph; Kurzrock, Razelle

doi:10.1634/theoncologist.2010-0308

Cited by 8 publications

(5 citation statements)

References 58 publications

(57 reference statements)

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“…We retrospectively reviewed the clinical outcomes of 229 consecutive patients with lung, pancreatic, and head and neck cancers who were treated in the phase 1 clinic at MD Anderson from September 2004 to September 2009. [10][11][12] All patients with these diseases who were treated in the clinic were included. The patients were treated on a total of 57 trials, and we treated anywhere from 1 patient to >20 patients on any given trial.…”

Section: Patientsmentioning

confidence: 99%

Validation of the royal marsden hospital prognostic score in patients treated in the phase I clinical trials program at the MD Anderson Cancer Center

Garrido‐Laguna

Janků

Vaklavas

et al. 2011

Cancer

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BACKGROUND:The authors validated the Royal Marsden Hospital (RMH) prognostic score in patients with advanced lung, pancreatic, and head and neck cancers who were enrolled on phase 1 trials in the MD Anderson Cancer Center Phase I Clinical Trials Program. METHODS: The RMH score uses albumin ( 3.5 g/dL vs <3.5 g/dL), lactate dehydrogenase (less than or equal to the upper limit of normal [ ULN] vs >ULN), and the number of metastatic sites ( 2 sites vs 3 sites) to predict patient survival in phase 1 trials. The authors of this report retrospectively reviewed the outcomes of 229 consecutive patients with lung, pancreatic, and head and neck tumors who were treated on 57 phase 1 trials. RESULTS: Two hundred twenty-nine consecutive patients with lung cancer (N ¼ 85), pancreatic cancer (N ¼ 83), and head and neck tumors (N ¼ 61) were treated. The median patient age was 60 years (range, 26-85 years), and 63% of the patients were men. Patients with a good RMH prognostic score (0-1) at baseline had a longer median survival than patients with a poor prognostic score (2-3; 33.9 weeks vs 21.1 weeks; P < .0001). The RMH score was an independent variable that predicted survival in multivariate analysis. Other independent variables that predicted better survival were hemoglobin level ( 10.5 g/dL), Eastern Cooperative Oncology Group performance status (0-1), and tumor type. Patients who were treated on first-in-human trials did not fare worse compared with those who were not treated on first-in-human trials. CONCLUSIONS: For patients with lung, pancreatic, and head and neck tumors who were treated on phase 1 trials, survival was predicted accurately by the RMH prognostic score.

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Section: Patientsmentioning

confidence: 99%

Validation of the royal marsden hospital prognostic score in patients treated in the phase I clinical trials program at the MD Anderson Cancer Center

Garrido‐Laguna

Janků

Vaklavas

et al. 2011

Cancer

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“…Patients receiving more than five prior treatments had a trend toward shorter survival4. A longer median PFS has been observed in lung cancer patients treated on phase I studies that had received two or less prior therapies compared to lung cancer patients treated with more than two prior therapies5. While it appears that PFS tends to get shorter for a number of factors (e.g.…”

Section: Introductionmentioning

confidence: 99%

Progression-free Survival Decreases with Each Subsequent Therapy in Patients Presenting for Phase I Clinical Trials

Bailey¹,

Jameson²,

Sima³

et al. 2012

J. Cancer

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Background: There is often a finite progression-free interval of time between one systemic therapy and the next when treating patients with advanced cancer. While it appears that progression-free survival (PFS) between systemic therapies tends to get shorter for a number of factors, there has not been a formal evaluation of diverse tumor types in an advanced cancer population treated with commercially-available systemic therapies.Methods: In an attempt to clarify the relationship between PFS between subsequent systemic therapies, we analyzed the records of 165 advanced cancer patients coming to our clinic for consideration for participation in six different phase I clinical trials requiring detailed and extensive past medical treatment history documentation.Results: There were 77 men and 65 women meeting inclusion criteria with a median age at diagnosis of 55.3 years (range 9.4-81.6). The most common cancer types were colorectal (13.9%), other gastrointestinal (11.8%), prostate (11.8%). A median of 3 (range 1-11) systemic therapies were received prior to phase I evaluation. There was a significant decrease in PFS in systemic therapy for advanced disease from treatment 1 to treatment 2 to treatment 3 (p = 0.002), as well as, from treatment 1 through treatment 5 (p < 0.001).Conclusions: In an advanced cancer population of diverse tumor types, we observe a statistically significant decrease in PFS with each successive standard therapy. Identification of new therapies that reverse this trend of decreasing PFS may lead to improved clinical outcomes.

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“…This is the third study to summarize the clinical outcomes of patients with advanced/metastatic NSCLC enrolled in phase I clinical trials [24,25]. Despite the availability of several new therapies, the survival of metastatic NSCLC patients remains dismal.…”

Section: Discussionmentioning

confidence: 99%

“…Among other prognostic factors, the number of prior lines of treatment remained a statistically significant factor for longer survival. Janku et al [24] also identified the ECOG PS score 2 or fewer organ systems involved and the number of prior lines as prognostics factors for survival. Also in their experience, the albumin and LDH rates were not statistically relevant prognostic factors for survival.…”

Section: Discussionmentioning

confidence: 99%

Clinical Benefit for Patients with Non-Small Cell Lung Cancer Enrolled in Phase I Trials

Lévy

Gomez‐Roca²,

Massard³

et al. 2013

Oncol Res Treat

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Aim: To analyze the clinical features and outcomes of advanced non-small cell lung cancer (NSCLC) patients treated in phase I trials. Patients and Methods: The clinical characteristics, efficacy and toxicity data of 70 pretreated NSCLC patients enrolled in 17 phase I trials between January 2005 and June 2010 were analyzed at our institution. Results: The histological types were: adenocarcinoma (79%), squamous cell carcinoma (13%), and others. Patients received a median number of 3 prior lines of treatment before inclusion. 1 complete response (CR), 11 (16%) partial responses (PRs), and 29 (41%) stable diseases (SDs) were observed (according to Response Evaluation Criteria in Solid Tumors (RECIST)). The median overall survival (OS) time was 18 months and the median progression-free survival (PFS) time was 4.1 months. The median PFS of these patients within their prior therapy line before phase I inclusion was 4.3 months. A performance status score of 0 and the number of prior lines of treatment were significant for OS and PFS in multivariate analysis, respectively. Grade 3/4 toxicities were observed in 20 (27%) patients, and there was 1 treatment-related death. Conclusion: Patients in good general condition and with limited pretreatment derived an improved benefit, suggesting that phase I studies may be a valid option for pretreated NSCLC patients.

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Outcomes of Patients with Advanced Non-Small Cell Lung Cancer Treated in a Phase I Clinic

Cited by 8 publications

References 58 publications

Validation of the royal marsden hospital prognostic score in patients treated in the phase I clinical trials program at the MD Anderson Cancer Center

Validation of the royal marsden hospital prognostic score in patients treated in the phase I clinical trials program at the MD Anderson Cancer Center

Progression-free Survival Decreases with Each Subsequent Therapy in Patients Presenting for Phase I Clinical Trials

Clinical Benefit for Patients with Non-Small Cell Lung Cancer Enrolled in Phase I Trials

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