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7. Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12

Author

Beltran-Bless, Ana-Alicia, Clemons, Mark J., Fesl, Christian, Greil, Richard, Pond, Gregory R., Balic, Marija, Vandermeer, Lisa, Bjelic-Radisic, Vesna, Singer, Christian F., Steger, Guenther G., Helfgott, Ruth, Egle, Daniel, Sölkner, Lidija, Gampenrieder, Simon P., Kacerovsky-Strobl, Stephanie, Suppan, Christoph, Ritter, Magdalena, Rinnerthaler, Gabriel, Pfeiler, Georg, Fohler, Hannes, Hlauschek, Dominik, Hilton, John, and Gnant, Michael

Published
2023
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14. The importance of greater speed in drug development for advanced malignancies

Author

Stewart, David J, Stewart, Andrew A, Wheatley‐Price, Paul, Batist, Gerald, Kantarjian, Hagop M, Schiller, Joan, Clemons, Mark, Bradford, John‐Peter, Gillespie, Laurel, and Kurzrock, Razelle

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Good Health and Well Being, Algorithms, Antineoplastic Agents, Clinical Trials as Topic, Drug Approval, Drug Development, Humans, Neoplasms, Survival Analysis, Time Factors, Treatment Outcome, Cancer, drug approval, drug development, life-years saved, Biochemistry and Cell Biology, Oncology and carcinogenesis
Abstract

It takes on average 6-12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life-years potentially saved if selected agents were approved more rapidly. As illustrative examples, we used 27 trials documenting improvements in survival. We multiplied improvement in median survival by numbers of patients dying annually and multiplied this by number of years from drug discovery until approval. For every year by which time to drug approval could have been shortened, there would have been a median number of life-years potentially saved of 79,920 worldwide per drug. Median number of life-years lost between time of drug discovery and approval was 1,020,900 per example. If we were able to use available opportunities to decrease the time required to take a drug from discovery to approval to 5 years, the median number of life-years saved per example would have been 523,890 worldwide. Various publications have identified opportunities to speed drug development without sacrificing patient safety. While many investigational drugs prove to be ineffective, some significantly prolong survival and/or reduce suffering. These illustrative examples suggest that a substantial number of life-years could potentially be saved by increasing the efficiency of development of new drugs for advanced malignancies.

Published
2018

16. The REthinking Clinical Trials Program Retreat 2023: Creating Partnerships to Optimize Quality Cancer Care

Author

Beltran-Bless, Ana-Alicia, primary, Clemons, Mark, additional, Vandermeer, Lisa, additional, El Emam, Khaled, additional, Ng, Terry L., additional, McGee, Sharon, additional, Awan, Arif Ali, additional, Pond, Gregory, additional, Renaud, Julie, additional, Barton, Gwen, additional, Hutton, Brian, additional, and Savard, Marie-France, additional

Published
2024
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17. Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer

Author

Clemons, Mark, Liu, Michelle, Stober, Carol, Pond, Gregory, Jemaan Alzahrani, Mashari, Ong, Michael, Ernst, Scott, Booth, Christopher, Mates, Mihaela, Abraham Joy, Anil, Aseyev, Olexiy, Blanchette, Phillip, Vandermeer, Lisa, Tu, Megan, Thavorn, Kednapa, and Fergusson, Dean

Published
2021
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19. Impact of the menstrual cycle on commercial prognostic gene signatures in oestrogen receptor-positive primary breast cancer

Author

Haynes, Ben P., Schuster, Gene, Buus, Richard, Alataki, Anastasia, Ginsburg, Ophira, Quang, Le Hong, Han, Pham Thi, Khoa, Pham Hong, Van Dinh, Nguyen, Van To, Ta, Clemons, Mark, Holcombe, Chris, Osborne, Caroline, Evans, Abigail, Skene, Anthony, Sibbering, Mark, Rogers, Clare, Laws, Siobhan, Noor, Lubna, Cheang, Maggie Chon U., Cleator, Susan J., Smith, Ian E., and Dowsett, Mitch

Published
2021
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21. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Baselga, José, Im, Seock-Ah, Iwata, Hiroji, Cortés, Javier, De Laurentiis, Michele, Jiang, Zefei, Arteaga, Carlos L, Jonat, Walter, Clemons, Mark, Ito, Yoshinori, Awada, Ahmad, Chia, Stephen, Jagiełło-Gruszfeld, Agnieszka, Pistilli, Barbara, Tseng, Ling-Ming, Hurvitz, Sara, Masuda, Norikazu, Takahashi, Masato, Vuylsteke, Peter, Hachemi, Soulef, Dharan, Bharani, Di Tomaso, Emmanuelle, Urban, Patrick, Massacesi, Cristian, and Campone, Mario

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Estrogen, Clinical Trials and Supportive Activities, Breast Cancer, Cancer, Aging, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Alanine Transaminase, Aminopyridines, Antineoplastic Combined Chemotherapy Protocols, Aspartate Aminotransferases, Biomarkers, Tumor, Breast Neoplasms, Class I Phosphatidylinositol 3-Kinases, DNA Mutational Analysis, DNA, Neoplasm, Disease-Free Survival, Double-Blind Method, Drug Eruptions, Estradiol, Exanthema, Female, Fulvestrant, Humans, Hyperglycemia, Middle Aged, Morpholines, Neoplasm Metastasis, Phosphatidylinositol 3-Kinases, Postmenopause, Receptor, ErbB-2, Receptors, Estrogen, Receptors, Progesterone, Response Evaluation Criteria in Solid Tumors, Retreatment, Signal Transduction, Survival Rate, Receptor, erbB-2, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundPhosphatidylinositol 3-kinase (PI3K) pathway activation is a hallmark of endocrine therapy-resistant, hormone receptor-positive breast cancer. This phase 3 study assessed the efficacy of the pan-PI3K inhibitor buparlisib plus fulvestrant in patients with advanced breast cancer, including an evaluation of the PI3K pathway activation status as a biomarker for clinical benefit.MethodsThe BELLE-2 trial was a randomised, double-blind, placebo-controlled, multicentre study. Postmenopausal women aged 18 years or older with histologically confirmed, hormone receptor-positive and human epidermal growth factor (HER2)-negative inoperable locally advanced or metastatic breast cancer whose disease had progressed on or after aromatase inhibitor treatment and had received up to one previous line of chemotherapy for advanced disease were included. Eligible patients were randomly assigned (1:1) using interactive voice response technology (block size of 6) on day 15 of cycle 1 to receive oral buparlisib (100 mg/day) or matching placebo, starting on day 15 of cycle 1, plus intramuscular fulvestrant (500 mg) on days 1 and 15 of cycle 1, and on day 1 of subsequent 28-day cycles. Patients were assigned randomisation numbers with a validated interactive response technology; these numbers were linked to different treatment groups which in turn were linked to treatment numbers. PI3K status in tumour tissue was determined via central laboratory during a 14-day run-in phase. Randomisation was stratified by PI3K pathway activation status (activated vs non-activated vs and unknown) and visceral disease status (present vs absent). Patients, investigators, local radiologists, study team, and anyone involved in the study were masked to the identity of the treatment until unblinding. The primary endpoints were progression-free survival by local investigator assessment per Response Evaluation Criteria In Solid Tumors (version 1.1) in the total population, in patients with known (activated or non-activated) PI3K pathway status, and in PI3K pathway-activated patients. Efficacy analyses were done in the intention-to-treat population. Safety was analysed in all patients who received at least one dose of study drug and had at least one post-baseline safety assessment according to the treatment they received. This trial is registered with ClinicalTrials.gov, number NCT01610284, and is currently ongoing but not recruiting participants.FindingsBetween Sept 7, 2012, and Sept 10, 2014, 1147 patients from 267 centres in 29 countries were randomly assigned to receive buparlisib (n=576) or placebo plus fulvestrant (n=571). In the total patient population (n=1147), median progression-free survival was 6·9 months (95% CI 6·8-7·8) in the buparlisib group versus 5·0 months (4·0-5·2) in the placebo group (hazard ratio [HR] 0·78 [95% CI 0·67-0·89]; one-sided p=0·00021). In patients with known PI3K status (n=851), median progression-free survival was 6·8 months (95% CI 5·0-7·0) in the buparlisib group vs 4·5 months (3·3-5·0) in the placebo group (HR 0·80 [95% CI 0·68-0·94]; one-sided p=0·0033). In PI3K pathway-activated patients (n=372), median progression-free survival was 6·8 months (95% CI 4·9-7·1) in the buparlisib group versus 4·0 months (3·1-5·2) in the placebo group (HR 0·76 [0·60-0·97], one-sided p=0·014). The most common grade 3-4 adverse events in the buparlisib group versus the placebo group were increased alanine aminotransferase (146 [25%] of 573 patients vs six [1%] of 570), increased aspartate aminotransferase (103 [18%] vs 16 [3%]), hyperglycaemia (88 [15%] vs one [

Published
2017

27. A Randomized Trial Comparing Concurrent versus Sequential Radiation and Endocrine Therapy in Early-Stage, Hormone-Responsive Breast Cancer.

Author

McGee, Sharon F., Clemons, Mark, Pond, Gregory, Caudrelier, Jean-Michel, Liu, Michelle, Alzahrani, Mashari Jemaan, Ng, Terry L., Awan, Arif A., Sehdev, Sandeep, Hilton, John, Savard, Marie-France, Fallowfield, Lesley, Kumar, Vikaash, Freedman, Orit, Vandermeer, Lisa, Hutton, Brian, and Bourque, Jean-Marc

Subjects
*HORMONE therapy, *RADIOTHERAPY complications, *RADIATION doses, *RADIOTHERAPY, *CANCER treatment
Abstract

Concerns exist regarding increased toxicities, including endocrine therapy toxicity, with concurrent radiation and endocrine therapy in early breast cancer (EBC). We present a pragmatic, randomized trial comparing concurrent versus sequential endocrine and radiotherapy in hormone-responsive EBC. In this multicenter trial, patients were randomized to receive adjuvant endocrine therapy concurrent with, or sequential to, radiotherapy. The primary outcome was change in endocrine therapy toxicity from baseline to 3 months post radiotherapy using the Functional Assessment of Cancer Therapy–Endocrine Symptom (FACT-ES) score. From September 2019 to January 2021, 133 patients were randomized to concurrent endocrine and radiotherapy, and 127 to sequential treatment. Most patients were post-menopausal (72.7%, 189/260) with stage 1 disease (65.8%, 171/260). Tamoxifen was the endocrine therapy of choice for 69.6% (181/260) of patients, and an aromatase inhibitor for the remainder. The median total radiation dose and fractions were 40.1 Gray (range 26–50) and 15 fractions (range 5–25), respectively. For the primary outcome of change in endocrine therapy toxicity per FACT-ES scores from baseline to 3 months post radiotherapy, no significant difference was found between the groups (median [range] = −4.9 (−82, 38.8) for concurrent and −5.1 (−42, 40) for sequential, p = 0.87). This is the first trial to investigate the impact of concurrent versus sequential adjuvant endocrine and radiotherapy on endocrine therapy-related toxicities. The findings provide further support to allow the optimal timing of radiation and endocrine therapy to be tailored for the individual patient. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Does Pre-Emptive Availability of PREDICT 2.1 Results Change Ordering Practices for Oncotype DX? A Multi-Center Prospective Cohort Study

Author

Awan, Arif Ali, primary, Saunders, Deanna, additional, Pond, Gregory, additional, Hamm, Caroline, additional, Califaretti, Nadia, additional, Mates, Mihaela, additional, Kumar, Vikaash, additional, Ibrahim, Mohammed F. K., additional, Beltran-Bless, Ana-Alicia, additional, Vandermeer, Lisa, additional, Hilton, John, additional, and Clemons, Mark, additional

Published
2024
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36. Evaluation of Unsolicited Feedback from Patients with Cancer and Their Families as a Strategy to Improve Cancer Care Delivery.

Author

Fallah, Parvaneh, Clemons, Lucas, Bradbury, Michelle, Vandermeer, Lisa, Clemons, Mark, Renaud, Julie, and Savard, Marie-France

Subjects
PATIENTS' families, CANCER patients, CANCER treatment, PATIENT experience, PATIENTS' attitudes
Abstract

Background: Unsolicited patient feedback (compliments and complaints) should allow the healthcare system to address and improve individual and overall patient, family, and staff experiences. We evaluated feedback at a tertiary cancer centre to identify potential areas for optimizing care delivery. Methods: unsolicited feedback submitted to the Patient Relations Department, relating to the Divisions of Medical and Radiation Oncology, at the Ottawa Hospital, was analyzed. Results: Of 580 individual reports submitted from 2016 to 2022, patient demographics were available for 97% (563/580). Median patient age was 65 years (range 17–101), and 53% (301/563) were female. The most common cancer types were breast (127/545, 23%) and gastrointestinal (119/545, 22%) malignancies, and most (64%, 311/486) patients had metastatic disease. Feedback was submitted mainly by patients (291/579, 50%), and predominantly negative (489/569, 86%). The main reasons for complaints included: communication (29%, 162/566) and attitude/conduct of care (28%, 159/566). While feedback rates were initially stable, an increase occurred from 2019 to 2021. Conclusions: Unsolicited feedback remains mostly negative, and relates to physician communication. If we are to drive meaningful changes in care delivery, more standardized means of assessing feedback and implementation strategies are needed. In addition, in an era of increased healthcare provider burnout, strategies to enhance formal positive feedback are also warranted. [ABSTRACT FROM AUTHOR]

Published
2024
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37. Evaluating the Utility and Privacy of Synthetic Breast Cancer Clinical Trial Data Sets

Author

El Kababji, Samer, primary, Mitsakakis, Nicholas, additional, Fang, Xi, additional, Beltran-Bless, Ana-Alicia, additional, Pond, Greg, additional, Vandermeer, Lisa, additional, Radhakrishnan, Dhenuka, additional, Mosquera, Lucy, additional, Paterson, Alexander, additional, Shepherd, Lois, additional, Chen, Bingshu, additional, Barlow, William E., additional, Gralow, Julie, additional, Savard, Marie-France, additional, Clemons, Mark, additional, and El Emam, Khaled, additional

Published
2023
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43. Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC)

Author

Clemons, Mark, Mazzarello, Sasha, Hilton, John, Joy, Anil, Price-Hiller, Julie, Zhu, Xiaofu, Verma, Shailendra, Kehoe, Anne, Ibrahim, Mohammed FK, Sienkiewicz, Marta, Stober, Carol, Vandermeer, Lisa, Hutton, Brian, Mallick, Ranjeeta, and Fergusson, Dean

Published
2019
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44. A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer

Author

Fernandes, Ricardo, primary, Ng, Terry L., additional, Alzahrani, Mashari Jemaan, additional, Raphael, Jacques, additional, Blanchette, Phillip, additional, Black, Morgan, additional, Stober, Carol, additional, Pond, Gregory R., additional, Cella, David, additional, Vandermeer, Lisa, additional, Ibrahim, Mohammed, additional, and Clemons, Mark, additional

Published
2023
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45. Can routinely collected administrative data effectively be used to evaluate and validate endpoints used in breast cancer clinical trials? Protocol for a scoping review of the literature

Author

Shah, Hely, primary, Wolfe, Dianna, additional, Clemons, Mark, additional, Liu, Michelle, additional, Thavorn, Kednapa, additional, Veroniki, Areti-Angeliki, additional, Lunny, Carole, additional, Pond, Greg, additional, McGee, Sharon, additional, Skidmore, Becky, additional, Arnaout, Angel, additional, and Hutton, Brian, additional

Published
2023
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