Progression-Free Survival as a Primary End-Point: Counting the Cost DOI Open Access
Ogochukwu Izuegbuna

Qeios, Journal Year: 2023, Volume and Issue: 5(12)

Published: Dec. 6, 2023

For some time in cancer clinical trials, overall survival (OS) has been the gold standard determining endpoint of a drug's efficacy. However, recent times, there gradual shift drug efficacy towards progression-free (PFS). PFS its merits, especially being cost-effective, but it is not without associated shortcomings. an ideal surrogate for OS, and cases, correlation low to medium strength, with heterogeneity methodologies used. There have also cases where used as place which was achieved, increased reports significant adverse events reduced quality life (QoL) index. Current realities make using OS trials difficult task demonstrate. even if used, data must be thoroughly assessed indices safety. It therefore important that stakeholders business evaluation note risks benefits such drugs target population. In so doing, patient’s QoL would paramount therapeutic decision-making.

Language: Английский

Clinical Outcomes in Patients with Early Stage Node-Negative HER2-Positive Breast Cancer Receiving Upfront Surgery or Neoadjuvant Systemic Therapy DOI

Natasha Muppidi,

Taiwo Adesoye, Min Yi

et al.

Annals of Surgical Oncology, Journal Year: 2024, Volume and Issue: 31(13), P. 8795 - 8801

Published: Aug. 27, 2024

Language: Английский

Citations

2
Abemaciclib Therapy Using the MonarchE Criteria Results in Large Numbers of Excess Axillary Node Clearances—Time to Pause and Reflect? DOI Open Access

D Ahari,

Mark Wilkinson, Nisha Ali

et al.

Cancers, Journal Year: 2024, Volume and Issue: 16(17), P. 3072 - 3072

Published: Sept. 4, 2024

The monarchE study added the CDK4/6 inhibitor abemaciclib to care of women with oestrogen-positive (ER+) breast cancers. Eligibility required meeting criteria—either >3 positive axillary nodes, or 1–3 sentinel nodes (SNB+) tumour size >50 mm grade 3 Women were advised proceed completion node clearance (cANC) if size/grade criteria not fulfilled for be identified. However, cANC is associated significant morbidity, conflicting potential benefits abemaciclib. We analysed data 229 consecutive (2016-2022) ER+ cancer and SNB+ who proceeded cANC, keeping contemporary treatment guidelines. used this cohort assess numbers that, under national guidance in place currently, would undergo solely check eligibility treatment. Using criteria, 90 (39%) have accessed based on size/grade, without cANC. In total, 139 been eligibility, only 15/139 (11%) having after biopsy remaining 124 (89%) undergone but remained ineligible Size, age, grade, Ki67 did predict at Following a large majority ER+, <50 mm, 1–2 tumours remain yet are subject morbidity including lifelong lymphoedema risk. authors state that 15 need therapy 1 clinically benefit. Thus, our cohort, undergoing lead one woman benefitting.

Language: Английский

Citations

1
Hormones as a double-edged sword: the role of hormones in cancer progression and the potential of targeted hormone therapies DOI
D.V. Joshi,

Janaki Patel,

Manit Munshi

et al.

Medical Oncology, Journal Year: 2024, Volume and Issue: 41(11)

Published: Oct. 14, 2024

Language: Английский

Citations

0
Progression-free survival as a primary end-point: Counting the cost DOI Open Access
Ogochukwu Izuegbuna

Qeios, Journal Year: 2023, Volume and Issue: unknown

Published: Oct. 26, 2023

For some time in cancer clinical trials, overall survival (OS) has been the gold standard determining endpoint of drug's efficacy. However, recent times, there a gradual shift drug efficacy towards progression-free (PFS). PFS its merits, especially being cost-effective, but not without associated shortcomings. is an ideal surrogate for OS, and cases, correlation low to medium strength with heterogeneity methodologies used. There have also cases where used as place which was achieved, increased reports significant adverse events/reduced quality life (QoL) index. Current realities make using OS trials difficult task demonstrate. even if used, data must be thoroughly assessed indices safety. It therefore important that stakeholders business evaluation note risks benefits such drugs target population. In so doing, patient’s QoL would paramount therapeutic decision-making.

Language: Английский

Citations

0
Progression-Free Survival as a Primary End-Point: Counting the Cost DOI Open Access
Ogochukwu Izuegbuna

Qeios, Journal Year: 2023, Volume and Issue: 5(12)

Published: Dec. 6, 2023

For some time in cancer clinical trials, overall survival (OS) has been the gold standard determining endpoint of a drug's efficacy. However, recent times, there gradual shift drug efficacy towards progression-free (PFS). PFS its merits, especially being cost-effective, but it is not without associated shortcomings. an ideal surrogate for OS, and cases, correlation low to medium strength, with heterogeneity methodologies used. There have also cases where used as place which was achieved, increased reports significant adverse events reduced quality life (QoL) index. Current realities make using OS trials difficult task demonstrate. even if used, data must be thoroughly assessed indices safety. It therefore important that stakeholders business evaluation note risks benefits such drugs target population. In so doing, patient’s QoL would paramount therapeutic decision-making.

Language: Английский

Citations

0