V1
Progression-Free Survival (PFS) in a Case-Series of Patients Treated With Palbociclib (Palb) for Metastatatic Breast Cancer (MBC) in Medellín, Colombia.
Authors: Diego Morán, Beatriz Preciado, Camila Lema, Mauricio Luján, Ruben D. Salazar, Alicia Henao, Andrés Yepes, Mauricio Lema
Affiliation: Clínica de Oncología, Astorga, Medellín.
Introduction: In Colombia, 3,702 people each year die of MBC, and it accounts for 8% of cancer related deaths. Endocrine therapy (ET) is the backbone for the initial therapy for most patients with Hormone-Receptor Positive / HER2 negative (HR+/HER2-) MBC. Disease control over several months is the rule, responses are infrequent, and eventual progression is the rule. The advent of aromatase inhibitors (AI) and fulvestrant (Fulv) have improved PFS and overall survival (OS) over older agents. With AI and/or Fulv in first-line (1L) ET the expected PFS and OS are about 14 months and 25 months, respectively. The addition of cdk4/6 inhibitors (iCDK) to ET has improved PFS and OS. These results are consistent accross several trials, with an expected PFS of about 25 months and 10 months when iCDK are added to ET in 1L, and 2L, respectively. It is unknown if disease control can be achieved to the same extent with the use of iCDK in Colombia. This study aims to describe the PFS of patients treated with iCDK + ET in 1L or 2L therapy for MBC in a cancer care facility in Medellín, Colombia.
Methods: This is a case-series of all consecutive women with HR+/HER2- MBC treated with Palb (an iCDK) plus ET in the Clínica de Oncología Astorga, in Medellín, Colombia. Demographic data, as well as line of therapy in which Palb was used (1L vs 2L, and later), endocrine sensitivity (ES) defined as either one of the following: de-novo MBC or MBC that developed no sooner that 2 years of adjuvant ET was adjudicated. PFS was defined as the time elapsed from iCDK initiation and evidence of disease progression or death. OS was definde as the time elapsed from iCDK initiation and death. Descriptive statistics and Kaplan-Meier survival curves were devised.
Results: 31 patients were included in the analysis. No patient meeting the inclusion criteria was excluded. Median age was .... (range, ). Median time from breast-cancer diagnosis and MBC was ---- months (range, ). De novo MBC were --- (%). Palb was used in 1L and 2L in ---(%) and ---(%), respectively. XX patients (%) were ES. Letrozole (1L) and fulv (2L+) were the ET of ---- (%), ---(%) of patients, respectively. Treatment discontinuation was due to progressive disease in ---(%, 95% CI, --- to ----), and toxicity in --- (%, 95% CI, --- to ----). Median PFS was ---- (95% CI, --- to ----) months , --- (95% CI, --- to ----) months, --- (95% CI, --- to ----) months for the overall, 1L, and 2L, patient population, respectively (p= ..., NS). Median PFS was ---- (95% CI, --- to ----) months , --- (95% CI, --- to ----) months, for the ES and the non-ES population, respectively (p=..., NS).
Conclusion: In this case-series comprising patients treated in the real-world setting in Colombia we failed to reach the expected PFS with the use of Palb + ET. Small sample size and the retrospective nature of this study are its main limitations, and generalization of its results cannot be supported.
Number of words: 519
V2
Progression-Free Survival (PFS) in a Case-Series of Patients Treated With Palbociclib (palb) for Metastatatic Breast Cancer (MBC) in Medellín, Colombia.
Authors: Diego Morán, Beatriz Preciado, Camila Lema, Mauricio Luján, Ruben D. Salazar, Alicia Henao, Andrés Yepes, Mauricio Lema
Affiliation: Clínica de Oncología, Astorga, Medellín.
Introduction: Endocrine therapy (ET) is the backbone for the initial therapy in Hormone-Receptor Positive / HER2 negative (HR+/HER2-) MBC. PFS and OS are 14 months and 25 months with fulvestrant (fulv) in first-line (1L), respectively. Aromatase inhibitors (AI) in 1L have slightly inferior results. The addition of palbociclib (palb), a cdk4/6 inhibitor, to ET has improved PFS both in 1L, and in subsequent lines (2L+), in combination with letrozole (an AI) and fulv, respectively. The expected PFS in 1L and 2L+ are 25 months and 10 months, respectively. Disease control is supererior for Endocrine sensitive (ES) disease defined as either de-novo MBC or MBC arising after at least 2 years of adjuvant ET. Low-risk (LR) MBC, defined as metastatic disease confined only to bone/soft-tissue, also exhibit superior PFS to palb + ET. It is unknown if disease control can be achieved to the same extent with the use of palb+ET in Colombia. This study aims to describe the PFS of patients treated with palb+ET in 1L or 2L+ in a cancer center in Medellín, Colombia.
Methods: This is a case-series of palb+ET-treated patients at the Clínica de Oncología Astorga, in Medellín, Colombia. All consecutive patients fulfilling all of the following criteria were included: 1. MBC, 2. HR+, 3. HER2-, and therapy with an palb+ET. Key variables collected included: type of metastatic disease (LR vs non-LR), line in which palb+ET was used (1L vs 2L+), endocrine sensitivity (ES vs non-ES), PFS (time from palb+ET initiation to disease progression or death), and OS (time from palb+ET initiation to death). Kaplan-Meier survival curves were devised.
Results: All 31 patients fulfilling the inclusion criteria were included. None were excluded. Median age was .... (range, ). Median time from breast-cancer diagnosis and MBC was ---- months (range, ). De novo MBC were --- (%). --- (%) and ---- (%) patients presented with LR and ES MBC, respectively. Palb was used in 1L and 2L in ---(%) and ---(%), respectively. Letrozole (1L) and fulv (2L+) were the ET in ---- (%), ---(%), respectively. Treatment discontinuation was due to progressive disease in ---(%, 95% CI, --- to ----), and toxicity in --- (%, 95% CI, --- to ----). Median PFS was ---- (95% CI, --- to ----) months , --- (95% CI, --- to ----) months, --- (95% CI, --- to ----) months for the overall, 1L, and 2L, patient population, respectively (p= ..., NS). Median PFS was ---- (95% CI, --- to ----) months , --- (95% CI, --- to ----) months, ---- (95% CI, --- to ----) months, ---- (95% CI, --- to ----) months for the LR, non-LR, ES and non-ES population, respectively. OS was ---- (95% CI, --- to ----) months, ---- (95% CI, --- to ----) months in 1L and 2L+, respectively.
Conclusion: In this case-series comprising patients treated in the Real-World setting in Colombia we failed to reach the expected PFS with the use of Palb + ET. The small sample size and the retrospective nature of this study are its main limitations. Generalization of these results cannot be supported.
524 words.
V3.
Progression-Free Survival (PFS) in a Case-Series of Patients Treated With Palbociclib (palb) for Metastatatic Breast Cancer (MBC) in Medellín, Colombia.
Authors: Diego Morán, Beatriz Preciado, Camila Lema, Mauricio Luján, Ruben D. Salazar, Alicia Henao, Andrés Yepes, Mauricio Lema
Affiliation: Clínica de Oncología, Astorga, Medellín.
Introduction: The addition of palbociclib, an oral cdk4/6 inhibitor, to endocrine therapy (palb+ET) has improved PFS in Hormone-Receptor Positive / HER2 negative (HR+/HER2-) MBC in both first- (1L) and subsequent lines (2L+). The expected PFS in 1L (with letrozole, an aromatase inhibitor) and 2L+ (with fulvestrant) are 24.8 months and 9.5 months, respectively. Palb+ET PFS is superior in endocrine sensitive (ES) disease (de novo MBC or MBC with at least 2-year control with ET), and in Low-risk (LR) MBC (bone/soft tissue only metastases). It is unknown whether the same PFS can be achieved with palb+ET in Colombia. This study describe the PFS of palb+ET treated patients at the Clínica de Oncología Astorga (Astorga) in Medellín, Colombia.
Methods: This is a case-series of palb+ET-treated patients at Astorga. All consecutive patients fulfilling all the following criteria were included: 1. MBC, 2. HR+, 3. HER2-, 3. Treatment with palb+ET. Main variables: type of metastatic disease (LR vs non-LR), line in which palb+ET was used (1L vs 2L+), endocrine sensitivity (ES vs non-ES), PFS (time from palb+ET initiation to disease progression or death), and OS (time from palb+ET initiation to death). Kaplan-Meier survival curves were devised.
Results: All 31 patients fulfilling the inclusion criteria were included. Median age was .... (range, ). Median time from breast-cancer diagnosis and MBC was ---- months (range, ). De novo MBC were --- (%). --- (%) and ---- (%) patients presented with LR and ES MBC, respectively. Palb was used in 1L and 2L in ---(%) and ---(%), respectively. Letrozole (1L) and fulv (2L+) were the ET in ---- (%), ---(%), respectively. Treatment discontinuation was due to progressive disease in ---(%, 95% CI, --- to ----), and toxicity in --- (%, 95% CI, --- to ----). Median PFS was ---- (95% CI, --- to ----) months , --- (95% CI, --- to ----) months, --- (95% CI, --- to ----) months for the overall, 1L, and 2L, patient population, respectively (p= ..., NS). Median PFS was ---- (95% CI, --- to ----) months , --- (95% CI, --- to ----) months, ---- (95% CI, --- to ----) months, ---- (95% CI, --- to ----) months for the LR, non-LR, ES and non-ES population, respectively. OS was ---- (95% CI, --- to ----) months, ---- (95% CI, --- to ----) months in 1L and 2L+, respectively.
Conclusion: In this case-series comprising patients treated in the Real-World setting in Colombia we failed to reach the expected PFS with the use of palb+ET. The small sample size and the retrospective nature of this study are its main limitations. Generalization of these results cannot be supported.
435 words.
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