☆ 4.5 Review

Outcomes and endpoints of relevance in gynecologic cancer clinical trials

INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER (2023)

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Article Oncology

Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial

Paul DiSilvestro et al.

Summary: Maintenance therapy with olaparib showed sustained progression-free survival benefit in newly diagnosed advanced ovarian cancer patients with a BRCA mutation. After a 7-year follow-up, there was a clinically meaningful improvement in overall survival. The incidence of myelodysplastic syndrome and acute myeloid leukemia was low.

JOURNAL OF CLINICAL ONCOLOGY (2023)

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Article Medicine, General & Internal

Survival with Cemiplimab in Recurrent Cervical Cancer

K. S. Tewari et al.

Summary: Patients with recurrent cervical cancer after first-line platinum-containing chemotherapy showed significantly longer overall survival and progression-free survival when treated with Cemiplimab compared to single-agent chemotherapy. Overall, there was a higher objective response rate and lower incidence of grade 3 or higher adverse events in the Cemiplimab group.

NEW ENGLAND JOURNAL OF MEDICINE (2022)

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Article Medicine, General & Internal

Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer

V Makker et al.

Summary: Lenvatinib plus pembrolizumab significantly prolongs progression-free survival and overall survival compared to chemotherapy in advanced endometrial cancer patients.

NEW ENGLAND JOURNAL OF MEDICINE (2022)

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Editorial Material Oncology

VP2-2022: Prospective double-blind, randomized phase III ENGOT-EN5/GOG-3055/SIENDO study of oral selinexor/placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer

I. B. Vergote et al.

ANNALS OF ONCOLOGY (2022)

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Article Oncology

Further refining 2020 ESGO/ESTRO/ESP molecular risk classes in patients with early-stage endometrial cancer: A propensity score-matched analysis

Camilla Nero et al.

Summary: This study evaluated the integration of molecular features with clinicopathological findings in endometrial cancer classification to refine risk assessment. The results showed that the overall survival of patients significantly differed when molecular features were integrated. Further stratification within each risk class based on the most relevant prognostic features could better define the prognosis of patients with early-stage endometrial cancer.

CANCER (2022)

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Article Oncology

Interobserver and intraobserver variability of RECIST assessment in ovarian cancer

Michael Krasovitsky et al.

Summary: This study assessed the variability of target lesion selection and measurement according to RECIST version 1.1 in patients with ovarian cancer. The results showed significant variability among different observers and within the same observer in both selection and measurement. The factors with the lowest reproducibility were peritoneal lesions in selection and lymph node lesions in measurement.

INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER (2022)

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Article Oncology

Low-Dose Radiotherapy Reverses Tumor Immune Desertification and Resistance to Immunotherapy

Fernanda G. Herrera et al.

Summary: Developing strategies to inflame tumors is critical for increasing response to immunotherapy. Low-dose radiation reprograms the tumor microenvironment to promote T-cell infiltration and, when combined with immunotherapy, simultaneously mobilizes innate and adaptive immunity, predominantly CD4(+) effector T cells, for tumor control dependent on NKG2D. This combination induces important responses in patients with metastatic immune-cold tumors.

CANCER DISCOVERY (2022)

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Article Oncology

Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class

Joseph N. Samuel et al.

Summary: In this cohort study, only a small proportion of cancer drug RCTs showed benefits in global QOL with the experimental agent. These results demonstrated an association between QOL benefits and OS benefits, but no such association was observed for PFS benefits. Trials that failed to show improved QOL often reported their QOL outcomes more favorably.

JAMA ONCOLOGY (2022)

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Article Oncology

Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial

J. S. Frenel et al.

Summary: In the SOLO2 trial, maintenance olaparib showed significant improvement in patients with platinum-sensitive relapsed ovarian cancer (PSROC) and BRCA mutation. However, the efficacy of subsequent chemotherapy after olaparib treatment is still unknown.

ANNALS OF ONCOLOGY (2022)

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Article Oncology

A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45)

Bradley J. Monk et al.

Summary: This study evaluates the efficacy of rucaparib as a first-line maintenance treatment in ovarian cancer patients, showing significant benefits of rucaparib compared to placebo in patients with and without HRD.

JOURNAL OF CLINICAL ONCOLOGY (2022)

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Article Oncology

Linking the European Organisation for Research and Treatment of Cancer Item Library to the Common Terminology Criteria for Adverse Events

Alexandra Gilbert et al.

Summary: The purpose of this study was to classify symptomatic adverse events (AEs) from the EORTC Item Library using the Common Terminology Criteria for Adverse Events (CTCAE) framework, which may aid in selecting and using patient-reported outcomes in clinical trials and routine care.

JOURNAL OF CLINICAL ONCOLOGY (2022)

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Article Oncology

CA-125 KELIM as a Potential Complementary Tool for Predicting Veliparib Benefit: An Exploratory Analysis From the VELIA/GOG-3005 Study

Benoit You et al.

JOURNAL OF CLINICAL ONCOLOGY (2022)

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Article Oncology

Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Ignace Vergote et al.

LANCET ONCOLOGY (2022)

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Meeting Abstract Oncology

Overall survival results from ARIEL4: A phase III study assessing rucaparib vs chemotherapy in patients with advanced, relapsed ovarian carcinoma and a deleterious BRCA1/2 mutation

A. M. Oza et al.

ANNALS OF ONCOLOGY (2022)

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Meeting Abstract Oncology

Final overall survival (OS) results from the phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC)

I. L. Ray-Coquard et al.

ANNALS OF ONCOLOGY (2022)

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Article Oncology

Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial

Antonio Gonzalez-Martin et al.

Summary: Maintenance olaparib plus bevacizumab provided continued benefit beyond first progression in newly diagnosed, advanced ovarian cancer, with a significant improvement in PFS2 and a delay in time to second subsequent therapy or death compared to placebo plus bevacizumab.

EUROPEAN JOURNAL OF CANCER (2022)

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Article Oncology

Patient self-reporting of tolerability using PRO-CTCAE in a randomized double-blind, placebo-controlled phase II trial comparing gemcitabine in combination with adavosertib or placebo in patients with platinum resistant or refractory epithelial ovarian carcinoma

Ainhoa Madariaga et al.

Summary: This study evaluated the combination of gemcitabine and the wee1 inhibitor adavosertib in platinum-resistant or refractory ovarian cancer. The PRO-CTCAE assessment was used to capture self-reporting of symptomatic adverse events. The results showed that patients receiving gemcitabine/adavosertib had greater difficulty swallowing and higher fatigue severity compared to those receiving gemcitabine/placebo.

GYNECOLOGIC ONCOLOGY (2022)

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Article Obstetrics & Gynecology

Efficacy and safety of niraparib as maintenance treatment in patients with newly diagnosed advanced ovarian cancer using an individualized starting dose (PRIME Study): A randomized, double-blind, placebo-controlled, phase 3 trial (LBA 5)

Ning Li et al.

GYNECOLOGIC ONCOLOGY (2022)

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Article Oncology

Identification of Patients With Ovarian Cancer Experiencing the Highest Benefit From Bevacizumab in the First-Line Setting on the Basis of Their Tumor-Intrinsic Chemosensitivity (KELIM): The GOG-0218 Validation Study

Benoit You et al.

Summary: In patients with high-grade ovarian cancer, only those with high-risk disease and poor tumor chemosensitivity benefit from bevacizumab treatment, suggesting that bevacizumab may be prioritized for these patients.

JOURNAL OF CLINICAL ONCOLOGY (2022)

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Article Oncology

Clinical implications of plasma circulating tumor DNA in gynecologic cancer patients

Lindsey M. Charo et al.

Summary: The molecular characterization of gynecologic cancers through ctDNA analysis plays a vital role in determining prognosis and guiding personalized therapy. This study found that higher ctDNA mutation frequency is associated with poor overall survival, while therapy tailored to ctDNA alterations leads to improved outcomes. The concordance between tissue and ctDNA genomic results remains high, demonstrating the potential utility of ctDNA in individualizing cancer therapy for gynecologic cancer patients.

MOLECULAR ONCOLOGY (2021)

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Article Oncology

New approaches for targeting platinum-resistant ovarian cancer

Michelle McMullen et al.

Summary: Platinum drugs are crucial in ovarian cancer treatment, but resistance is a major challenge, with complex mechanisms involving both intracellular and microenvironment factors. Clinical trials are essential for improving outcomes, and future research should focus on understanding the biology of the disease and enhancing quality of life and survival for patients.

SEMINARS IN CANCER BIOLOGY (2021)

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Article Oncology

Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial

Susana Banerjee et al.

Summary: The study demonstrated that maintenance therapy with olaparib for 2 years can extend progression-free survival to over 4.5 years in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation. These results support the use of maintenance olaparib as a standard of care in this setting.

LANCET ONCOLOGY (2021)

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Article Medicine, General & Internal

Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

P. Harter et al.

Summary: The study demonstrates that in patients with recurrent ovarian cancer, secondary cytoreductive surgery followed by chemotherapy results in longer overall survival compared to chemotherapy alone. Quality of life measures did not differ significantly between the two treatment groups.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Oncology

Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial

Andres Poveda et al.

Summary: Olaparib provided a median overall survival benefit of 12.9 months compared with placebo in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation. Although statistical significance was not reached, these findings are arguably clinically meaningful and support the use of maintenance olaparib in these patients.

LANCET ONCOLOGY (2021)

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Article Oncology

Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial

Michael Friedlander et al.

Summary: Maintenance olaparib treatment in newly diagnosed, advanced ovarian cancer patients provides a significant progression-free survival benefit without detrimental effects on HRQOL. Quality-adjusted progression-free survival and time without significant toxicity symptoms were significantly longer in the olaparib group compared to the placebo group.

LANCET ONCOLOGY (2021)

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Article Obstetrics & Gynecology

Research biopsies in patients with gynecologic cancers: patient-reported outcomes, perceptions, and preferences

Ainhoa Madariaga et al.

Summary: This study prospectively assessed the impact of research biopsies on the quality of life in patients with gynecologic cancer, as well as patient-reported outcomes and factors associated with willingness to undergo sequential biopsies. Results showed that research biopsies were generally well accepted, with most patients (83%) willing to undergo serial biopsies if necessary. Addressing modifiable psychosocial aspects of the procedure may improve the experience with research biopsies for patients with gynecologic cancers.

AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY (2021)

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Meeting Abstract Oncology

Quality-adjusted time without symptom or toxicity (QA-TWiST) and quality-adjusted progression-free survival (QA-PFS) of first-line (1L) maintenance niraparib in patients with advanced ovarian cancer (OC): Results from the PRIMA trial

M-P. Barretina-Ginesta et al.

ANNALS OF ONCOLOGY (2021)

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Article Obstetrics & Gynecology

Long-term safety and secondary efficacy endpoints in the ENGOT-OV16/NOVA phase III trial of niraparib in recurrent ovarian cancer

Ursula Matulonis et al.

GYNECOLOGIC ONCOLOGY (2021)

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Article Medicine, General & Internal

Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer

N. Colombo et al.

Summary: Adding pembrolizumab to chemotherapy significantly improves progression-free and overall survival in patients with persistent, recurrent, or metastatic cervical cancer when compared to placebo. Anemia and neutropenia are the most common grade 3 to 5 adverse events.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Oncology

Everolimus, Letrozole, and Metformin in Women with Advanced or Recurrent Endometrioid Endometrial Cancer: A Multi-Center, Single Arm, Phase II Study

Pamela T. Soliman et al.

CLINICAL CANCER RESEARCH (2020)

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Article Oncology

Phase 2 study of the Exportin 1 inhibitor selinexor in patients with recurrent gynecological malignancies

I. B. Vergote et al.

GYNECOLOGIC ONCOLOGY (2020)

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Review Oncology

Manage wisely: poly (ADP-ribose) polymerase inhibitor (PARPi) treatment and adverse events

Ainhoa Madariaga et al.

INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER (2020)

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Article Oncology

Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial

Jonathan A Ledermann et al.

LANCET ONCOLOGY (2020)

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Article Pharmacology & Pharmacy

Relationship Between Progression-Free Survival, Objective Response Rate, and Overall Survival in Clinical Trials of PD-1/PD-L1 Immune Checkpoint Blockade: A Meta-Analysis

Jiabu Ye et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2020)

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Meeting Abstract Oncology

Time to first subsequent therapy (TFST) and progression-free survival 2 (PFS2) from the phase 3 randomized, double-blind PRIMA/ENGOT-OV26/GOG-3012 study in patients with newly diagnosed ovarian cancer

S. N. Han et al.

GYNECOLOGIC ONCOLOGY (2020)

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Article Oncology

Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma

Amit M. Oza et al.

JOURNAL OF CLINICAL ONCOLOGY (2020)

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Review Medicine, General & Internal

Assessment of Progression-Free Survival as a Surrogate End Point of Overall Survival in First-Line Treatment of Ovarian Cancer: A Systematic Review and Meta-analysis

Xavier Paoletti et al.

JAMA NETWORK OPEN (2020)

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Review Oncology

Measuring Quality of Life in Ovarian Cancer Clinical Trials-Can We Improve Objectivity and Cross Trial Comparisons?

Gita Bhat et al.

CANCERS (2020)

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Article Medicine, General & Internal

A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms

Philipp Harter et al.

NEW ENGLAND JOURNAL OF MEDICINE (2019)

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Article Cell Biology

Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions

Marina Bagnoli et al.

CELLS (2019)

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Article Oncology

Advancing Drug Development in Gynecologic Malignancies

Julia A. Beaver et al.

CLINICAL CANCER RESEARCH (2019)

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Article Oncology

Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer

Marcus E. Randall et al.

JOURNAL OF CLINICAL ONCOLOGY (2019)

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Article Oncology

Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial

Josep M. del Campo et al.

JOURNAL OF CLINICAL ONCOLOGY (2019)

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Article Medicine, General & Internal

Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer

Daniela Matei et al.

NEW ENGLAND JOURNAL OF MEDICINE (2019)

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Article Medicine, General & Internal

Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

A. Gonzalez-Martin et al.

NEW ENGLAND JOURNAL OF MEDICINE (2019)

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Article Medicine, General & Internal

Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer

Robert L. Coleman et al.

NEW ENGLAND JOURNAL OF MEDICINE (2019)

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Article Medicine, General & Internal

Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

I. Ray-Coquard et al.

NEW ENGLAND JOURNAL OF MEDICINE (2019)

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Review Oncology

A Systematic Review of Health-Related Quality of Life Reporting in Ovarian Cancer Phase III Clinical Trials: Room to Improve

Michelle K. Wilson et al.

ONCOLOGIST (2018)

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Article Oncology

Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial

Amit M. Oza et al.

LANCET ONCOLOGY (2018)

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Article Oncology

Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial

Michael Friedlander et al.

LANCET ONCOLOGY (2018)

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Article Oncology

Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial

Stephanie M. de Boer et al.

LANCET ONCOLOGY (2018)

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Review Oncology

Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup (GCIG): clinical trial design for rare ovarian tumours

A. F. Leary et al.

ANNALS OF ONCOLOGY (2017)

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Review Oncology

Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: recurrent disease

M. K. Wilson et al.

ANNALS OF ONCOLOGY (2017)

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Article Medicine, General & Internal

Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Robert L. Coleman et al.

LANCET (2017)

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Review Oncology

Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: first-line interventions

A. Karam et al.

ANNALS OF ONCOLOGY (2017)

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Article Oncology

Endpoints in clinical trials: What do patients consider important? A survey of the Ovarian Cancer National Alliance

Lindsey E. Minion et al.

GYNECOLOGIC ONCOLOGY (2016)

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Article Oncology

American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options

Lowell E. Schnipper et al.

JOURNAL OF CLINICAL ONCOLOGY (2015)

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Editorial Material Oncology

Design Issues in Randomized Clinical Trials of Maintenance Therapies

Boris Freidlin et al.

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE (2015)

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Review Oncology

Outcomes and endpoints in trials of cancer treatment: the past, present, and future

Michelle K. Wilson et al.

LANCET ONCOLOGY (2015)

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Review Oncology

Outcomes and endpoints in cancer trials: bridging the divide

Michelle K. Wilson et al.

LANCET ONCOLOGY (2015)

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Editorial Material Oncology

Design Issues in Randomized Clinical Trials of Maintenance Therapies

Boris Freidlin et al.

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE (2015)

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Article Oncology

CA-125 can be part of the tumour evaluation criteria in ovarian cancer trials: experience of the GCIG CALYPSO trial

J. Alexandre et al.

BRITISH JOURNAL OF CANCER (2012)

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Article Oncology

Predictive value of serum CA-125 levels in patients with persistent or recurrent epithelial ovarian cancer or peritoneal cancer treated with bevacizumab on a Gynecologic Oncology Group phase II trial

Leslie M. Randall et al.

GYNECOLOGIC ONCOLOGY (2012)

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Article Oncology

Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial

Binghe Xu et al.

CANCER CHEMOTHERAPY AND PHARMACOLOGY (2011)

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Article Oncology

Guidelines for the Development and Incorporation of Biomarker Studies in Early Clinical Trials of Novel Agents

Janet E. Dancey et al.

CLINICAL CANCER RESEARCH (2010)

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Review Oncology

Use of Meta-Analysis for the Validation of Surrogate Endpoints and Biomarkers in Cancer Trials

Marc Buyse

CANCER JOURNAL (2009)

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Article Oncology

New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)

E. A. Eisenhauer et al.

EUROPEAN JOURNAL OF CANCER (2009)

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Article Oncology

Interobserver and intraobserver variability in measurement of non-small-cell carcinoma lung lesions: Implications for assessment of tumor response

JJ Erasmus et al.

JOURNAL OF CLINICAL ONCOLOGY (2003)

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Article Oncology

Selection of active drugs for ovarian cancer based on CA-125 and standard response rates in phase II trials

GJS Rustin et al.

JOURNAL OF CLINICAL ONCOLOGY (2000)

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