Clinical outcome and prognostic markers for patients with gynecologic malignancies in phase 1 clinical trials: A single institution experience from 1999 to 2010

June Y. Hou, Santiago Aparo, Mohammad Ghalib, Imran Chaudhary, Umang Shah, Umang Swami, Mark Einstein, Gary L. Goldberg, Sridhar Mani, Sanjay Goel

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Abstract

Objectives. There is a scarcity of outcome data regarding phase 1 trials for patientswith gynecologic malignancy. The objective of this study was to assess toxicity, clinical benefit and prognosticators in gynecologic oncology patients participating in phase 1 trials. Methods. All phase 1 oncology trials conducted at Albert Einstein Cancer Center from 1999 to 2010 were reviewed and extracted for relevant demographic and clinical data concerning patients with gynecologic malignancy. Cox-proportional and logistic regression modeling were used for multivariate analysis. Results. 120 distinct patients with gynecologic malignancy participated in 41 trials, constituting 30.6% of all phase 1 patients enrolled in the same time period. The median age is 59 years. Out of the 184 patients enrolled, 160 individual responses were evaluable. Seventeen DLT events (9.2%) occurred, including 1 (0.5%) treatmentrelatedmortality. There were 27.2% ≥ grade 3 hematologic and 24.4% non-hematologic toxicity. Eighty patients had stable disease (SD, 50%), including 21.9% with SD ≥ 4 months, 11 (6.3%) with partial response (PR), and 3 (1.9%) achieving complete response (CR). The clinical benefit rate (CBR = SD + CR + PR) was 58.1%. Albumin (Alb) ≤ 3.5 g/dL and abnormal ANC were independent negative prognosticators of survival. We also found a continuous correlation between changes in Albumin (p = 0.02) and LDH (p = 0.02) and odds of achieving CBR ≥ 4 month. Conclusions. Our clinical outcome and safety data suggested that phase 1 trials may be a reasonable option for patients with advanced and recurrent gynecologic cancer. The potential prognosticators identified should be further validated in larger trials.

Original languageEnglish (US)
Pages (from-to)163-168
Number of pages6
JournalGynecologic Oncology
Volume131
Issue number1
DOIs
StatePublished - Jan 1 2013
Externally publishedYes

Fingerprint

Clinical Trials, Phase I
Neoplasms
Albumins
Multivariate Analysis
Logistic Models
Demography
Safety
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Obstetrics and Gynecology

Cite this

Hou, June Y. ; Aparo, Santiago ; Ghalib, Mohammad ; Chaudhary, Imran ; Shah, Umang ; Swami, Umang ; Einstein, Mark ; Goldberg, Gary L. ; Mani, Sridhar ; Goel, Sanjay. / Clinical outcome and prognostic markers for patients with gynecologic malignancies in phase 1 clinical trials : A single institution experience from 1999 to 2010. In: Gynecologic Oncology. 2013 ; Vol. 131, No. 1. pp. 163-168.
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abstract = "Objectives. There is a scarcity of outcome data regarding phase 1 trials for patientswith gynecologic malignancy. The objective of this study was to assess toxicity, clinical benefit and prognosticators in gynecologic oncology patients participating in phase 1 trials. Methods. All phase 1 oncology trials conducted at Albert Einstein Cancer Center from 1999 to 2010 were reviewed and extracted for relevant demographic and clinical data concerning patients with gynecologic malignancy. Cox-proportional and logistic regression modeling were used for multivariate analysis. Results. 120 distinct patients with gynecologic malignancy participated in 41 trials, constituting 30.6{\%} of all phase 1 patients enrolled in the same time period. The median age is 59 years. Out of the 184 patients enrolled, 160 individual responses were evaluable. Seventeen DLT events (9.2{\%}) occurred, including 1 (0.5{\%}) treatmentrelatedmortality. There were 27.2{\%} ≥ grade 3 hematologic and 24.4{\%} non-hematologic toxicity. Eighty patients had stable disease (SD, 50{\%}), including 21.9{\%} with SD ≥ 4 months, 11 (6.3{\%}) with partial response (PR), and 3 (1.9{\%}) achieving complete response (CR). The clinical benefit rate (CBR = SD + CR + PR) was 58.1{\%}. Albumin (Alb) ≤ 3.5 g/dL and abnormal ANC were independent negative prognosticators of survival. We also found a continuous correlation between changes in Albumin (p = 0.02) and LDH (p = 0.02) and odds of achieving CBR ≥ 4 month. Conclusions. Our clinical outcome and safety data suggested that phase 1 trials may be a reasonable option for patients with advanced and recurrent gynecologic cancer. The potential prognosticators identified should be further validated in larger trials.",
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Clinical outcome and prognostic markers for patients with gynecologic malignancies in phase 1 clinical trials : A single institution experience from 1999 to 2010. / Hou, June Y.; Aparo, Santiago; Ghalib, Mohammad; Chaudhary, Imran; Shah, Umang; Swami, Umang; Einstein, Mark; Goldberg, Gary L.; Mani, Sridhar; Goel, Sanjay.

In: Gynecologic Oncology, Vol. 131, No. 1, 01.01.2013, p. 163-168.

Research output: Contribution to journalArticle

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T2 - A single institution experience from 1999 to 2010

AU - Hou, June Y.

AU - Aparo, Santiago

AU - Ghalib, Mohammad

AU - Chaudhary, Imran

AU - Shah, Umang

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AU - Einstein, Mark

AU - Goldberg, Gary L.

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AU - Goel, Sanjay

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N2 - Objectives. There is a scarcity of outcome data regarding phase 1 trials for patientswith gynecologic malignancy. The objective of this study was to assess toxicity, clinical benefit and prognosticators in gynecologic oncology patients participating in phase 1 trials. Methods. All phase 1 oncology trials conducted at Albert Einstein Cancer Center from 1999 to 2010 were reviewed and extracted for relevant demographic and clinical data concerning patients with gynecologic malignancy. Cox-proportional and logistic regression modeling were used for multivariate analysis. Results. 120 distinct patients with gynecologic malignancy participated in 41 trials, constituting 30.6% of all phase 1 patients enrolled in the same time period. The median age is 59 years. Out of the 184 patients enrolled, 160 individual responses were evaluable. Seventeen DLT events (9.2%) occurred, including 1 (0.5%) treatmentrelatedmortality. There were 27.2% ≥ grade 3 hematologic and 24.4% non-hematologic toxicity. Eighty patients had stable disease (SD, 50%), including 21.9% with SD ≥ 4 months, 11 (6.3%) with partial response (PR), and 3 (1.9%) achieving complete response (CR). The clinical benefit rate (CBR = SD + CR + PR) was 58.1%. Albumin (Alb) ≤ 3.5 g/dL and abnormal ANC were independent negative prognosticators of survival. We also found a continuous correlation between changes in Albumin (p = 0.02) and LDH (p = 0.02) and odds of achieving CBR ≥ 4 month. Conclusions. Our clinical outcome and safety data suggested that phase 1 trials may be a reasonable option for patients with advanced and recurrent gynecologic cancer. The potential prognosticators identified should be further validated in larger trials.

AB - Objectives. There is a scarcity of outcome data regarding phase 1 trials for patientswith gynecologic malignancy. The objective of this study was to assess toxicity, clinical benefit and prognosticators in gynecologic oncology patients participating in phase 1 trials. Methods. All phase 1 oncology trials conducted at Albert Einstein Cancer Center from 1999 to 2010 were reviewed and extracted for relevant demographic and clinical data concerning patients with gynecologic malignancy. Cox-proportional and logistic regression modeling were used for multivariate analysis. Results. 120 distinct patients with gynecologic malignancy participated in 41 trials, constituting 30.6% of all phase 1 patients enrolled in the same time period. The median age is 59 years. Out of the 184 patients enrolled, 160 individual responses were evaluable. Seventeen DLT events (9.2%) occurred, including 1 (0.5%) treatmentrelatedmortality. There were 27.2% ≥ grade 3 hematologic and 24.4% non-hematologic toxicity. Eighty patients had stable disease (SD, 50%), including 21.9% with SD ≥ 4 months, 11 (6.3%) with partial response (PR), and 3 (1.9%) achieving complete response (CR). The clinical benefit rate (CBR = SD + CR + PR) was 58.1%. Albumin (Alb) ≤ 3.5 g/dL and abnormal ANC were independent negative prognosticators of survival. We also found a continuous correlation between changes in Albumin (p = 0.02) and LDH (p = 0.02) and odds of achieving CBR ≥ 4 month. Conclusions. Our clinical outcome and safety data suggested that phase 1 trials may be a reasonable option for patients with advanced and recurrent gynecologic cancer. The potential prognosticators identified should be further validated in larger trials.

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