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15 december 2020: Uit de eindevaluatie van de SOLAR-1 studie blijkt dat alpelisib in combinatie met fulvestrant geen statistisch significant verschil geeft in overall overleving. Maar het verschil is wel dusdanig groot (8 maanden tot 14 maanden voor patienten met lever en longuitzaaiingen) en voor met name de vrouwen met een PIK3CA mutatie dat het toch zinvol is om deze combinatiebehandeling aan te bieden aan vrouwen met uitgezaaide borstkanker HR pos. en Her2 neg.

Uit een persbericht:

De uiteindelijke algehele overlevingsanalyse van de SOLAR-1-studie die de toevoeging van alpelisib aan fulvestrant voor PIK3CA-gemuteerde HR-positieve, HER2-negatieve gevorderde borstkanker evalueert, wordt hier gepresenteerd. Eerdere resultaten van de SOLAR-1-studie rapporteerden een klinisch betekenisvol progressievrij overlevingsvoordeel. Helaas, ondanks meer dan 3 jaar analyse, voldeed de mediane totale overleving van 39,3 maanden voor de alpelisib plus fulvestrant-arm versus 31,4 maanden voor de placebo plus fulvestrant-arm (eenzijdige P = 0,15) niet aan de drempel voor significantie. Uit subgroepanalyse bleek dat bij patiënten met PIK3CA-gemuteerde ziekte gedetecteerd in plasma circulerend tumor-DNA, de mediane totale overleving 34,4 maanden was in de alpelisib plus fulvestrant-arm vergeleken met 25,2 maanden in de placebo plus fulvestrant-arm (HR, 0,74).

Hoewel er geen statistisch significant voordeel in algehele overleving werd gezien, concluderen de auteurs dat er een klinisch betekenisvol voordeel is van de toevoeging van alpelisib aan fulvestrant, aangezien een aanzienlijk deel van de patiënten enkele jaren na voltooiing van de studie onder behandeling blijft.

Het eindrapport: Alpelisib Plus Fulvestrant for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-2–Negative Advanced Breast Cancer: Final Overall Survival Results From SOLAR-1 is gratis in te zien.

Onderaan dit artikel het abstract.

22 mei 2020: Aanvullend op onderstaande informatie lees dit studierapport: Time Course and Management of Key Adverse Events During the Randomized Phase 3 SOLAR-1 Study of PI3K Inhibitor Alpelisib Plus Fulvestrant in Patients With HR-Positive Advanced Breast Cancer

De onderzoekers maakten een overzicht van hoe de bijwerkingen die kunnen ontstaan bij alpelisib in combinatie met fulvestrant kunnen worden gedoseerd en gereguleerd zodat borstkankerpatiënten daar de minste last van hebben.

Kernpunten uit de studie:

•Hyperglykemie, uitslag en diarree waren de meest voorkomende bijwerkingen van graad 3/4 bij patiënten die alpelisib kregen

•Deze bijwerkingen waren voorspelbaar, beheersbaar met gelijktijdige medicatie en over het algemeen omkeerbaar

•Implementatie van meer gedetailleerde richtlijnen voor AE-beheer verbeterde verschillende markers van veiligheid tijdens het onderzoek

29 mei 2019: Bron: FDA

De FDA - Federal Food and Drug Administration heeft het medicijn alpesilib (Pigray) aanvullend op fulvestrant goedgekeurd voor gebruik bij patienten met uitgezaaide borstkanker met Her2 negatief, ER pos. en PR pos. En specifiek op de PIK3CA mutatie.

Uit een gerandomiseerd onderzoek bij 572 vrouwen en mannen in leeftijd na de overgang blijkt dit medicijn de overall progressievrije ziekte te verdubbelen. (11 maanden vs 5,7 maanden) (zie abstract onderaan dit artikel) En zie studieprotocol: https://clinicaltrials.gov/ct2/show/NCT02437318

De goedkeuring van de FDA voor dit medicijn in een officieel persbericht:

For Immediate Release:: May 24, 2019

Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.

The FDA also approved the companion diagnostic test, therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue and/or a liquid biopsy. Patients who are negative by the therascreen test using the liquid biopsy should undergo tumor biopsy for PIK3CA mutation testing.

“Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer. The ability to target treatment to a patient’s specific genetic mutation or biomarker is becoming increasingly common in cancer treatment, and companion diagnostic tests assist oncologists in selecting patients who may benefit from these targeted treatments,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For this approval, we employed some of our newer regulatory tools to streamline reviews without compromising the quality of our assessment. This drug is the first novel drug approved under the Real-Time Oncology Review pilot program. We also used the updated Assessment Aid, a multidisciplinary review template that helps focus our written review on critical thinking and consistency and reduces time spent on administrative tasks.”

Metastatic breast cancer is breast cancer that has spread beyond the breast to other organs in the body (most often the bones, lungs, liver or brain). When breast cancer is hormone-receptor positive, patients may be treated with anti-hormonal treatment (also called endocrine therapy), alone or in combination with other medicines, or chemotherapy.

The efficacy of Piqray was studied in the SOLAR-1 trial, a randomized trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor. Results from the trial showed the addition of Piqray to fulvestrant significantly prolonged progression- free survival (median of 11 months vs. 5.7 months) in patients whose tumors had a PIK3CA mutation.

Common side effects of Piqray are high blood sugar levels, increase in creatinine, diarrhea, rash, decrease in lymphocyte count in the blood, elevated liver enzymes, nausea, fatigue, low red blood cell count, increase in lipase (enzymes released by the pancreas), decreased appetite, stomatitis, vomiting, weight loss, low calcium levels, aPTT prolonged (blood clotting taking longer to occur than it should), and hair loss.

Health care professionals are advised to monitor patients taking Piqray for severe hypersensitivity reactions (intolerance). Patients are warned of potentially severe skin reactions (rashes that may result in peeling and blistering of skin or mucous membranes like the lips and gums). Health care professionals are advised not to initiate treatment in patients with a history of severe skin reactions such as Stevens-Johnson Syndrome, erythema multiforme, or toxic epidermal necrolysis. Patients on Piqray have reported severe hyperglycemia (high blood sugar), and the safety of Piqray in patients with Type 1 or uncontrolled Type 2 diabetes has not been established. Before initiating treatment with Piqray, health care professionals are advised to check fasting glucose and HbA1c, and to optimize glycemic control. Patients should be monitored for pneumonitis/interstitial lung disease (inflammation of lung tissue) and diarrhea during treatment. Piqray must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

Piqray is the first new drug application (NDA) for a new molecular entity approved under the Real-Time Oncology Review (RTOR) pilot program, which permits the FDA to begin analyzing key efficacy and safety datasets prior to the official submission of an application, allowing the review team to begin their review and communicate with the applicant earlier. Piqray also used the updated Assessment Aid (AAid), a multidisciplinary review template intended to focus the FDA’s written review on critical thinking and consistency and reduce time spent on administrative tasks. With these two pilot programs, today’s approval of Piqray comes approximately three months ahead of the Prescription Drug User Fee Act (PDUFA) VI deadline of August 18, 2019.

The FDA granted this application Priority Review designation. The FDA granted approval of Piqray to Novartis. The FDA granted approval of the therascreen PIK3CA RGQ PCR Kit to QIAGEN Manchester, Ltd.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Treatment with alpelisib-fulvestrant prolonged progression-free survival among patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously.

2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.

Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer.

André F¹, Ciruelos E¹, Rubovszky G¹, Campone M¹, Loibl S¹, Rugo HS¹, Iwata H¹, Conte P¹, Mayer IA¹, Kaufman B¹, Yamashita T¹, Lu YS¹, Inoue K¹, Takahashi M¹, Pápai Z¹, Longin AS¹, Mills D¹, Wilke C¹, Hirawat S¹, Juric D¹; SOLAR-1 Study Group; the SOLAR-1 Study Group.

Collaborators (197)

Rubovszky G, Kaufman B, Yamashita T, Lu YS, Ciruelos Gil EM, Inoue K, Takahashi M, Pápai Z, Arnedos M, Stemmer S, Cerda H, Campone M, Tesch H, Jurado JC, Toledano I, Rodriguez W, Delgado Mingorance JI, Safra T, Park YH, Krivorotko P, Forget F, Levy C, Masuda N, Lee KH, Melisko M, Huober J, Singer C, Mouret Reynier MA, Iwata H, Iwase H, Sohn J, Yamauchi T, Tomova A, Schenker M, Niikura N, Ungureanu A, Sriuranpong V, Kaen D, Henning JW, Borrego MR, Kurteva G, Deleu GFI, Popov V, Garcia Saenz JA, Timar-David M, Kim J, Lopez Lopez R, Perello Martorell A, Takano T, Kattan J, Wright G, Yañez E, Mundhenke C, Aggarwal L, Nakayama T, Airoldi M, Ludmila L, Alonso Romero JL, Arnaud A, Bianchi GV, Denduluri N, Shtivelband M, Kowalyszyn R, Chouinard E, Farhat F, Sevillano Fernandez E, Bermejo de Las Heras B, Perez Garcia JM, De Toro Salas R, Tseng LM, Sandri I, Barbeaux A, Brust L, Provencher L, Leheurteur M, Nusch A, Yousuf AF, Conte P, Gonzalez Cortijo L, Awada A, Schmidt M, Gopichand M, Lee KS, Vallejos C, Villman K, Aieta M, Rocca A, Takashima S, Van Dijk M, Martinez de Duenas E, Yardley D, Grossi M, Spazzapan S, Reinoso Toledo JG, Ahmed S, Volkov N, Dieterich M, Chiu J, Kaklamani V, Cuff K, Sagara Y, Casalnuovo M, Huizing M, Kohoutek M, Dalenc F, Figueroa Martinez P, Ponce Lorenzo J, Donev I, Brezden-Masley C, Derbel O, Welslau M, Berardi R, Akewanlop C, Dimopoulos M, Gupta S, Tonini G, Natoli C, van de Wouw A, Neciosup S, Margeli Vila M, Nilsson C, Toppmeyer D, Marx G, Holeckova P, Kisro J, Park-Simon TW, Erfan J, Matsumoto K, Kim SB, Overton L, Fontaine C, Campone M, Priou F, Langanke D, Riseberg D, Juric D, Chap L, Dent S, Polikoff J, Varela M, Silva Melo Cruz FJ, Fernandez Abad M, Silverman P, Colangiovanni Girotto G, Fischer D, Allegrini G, Cunha Souza S, Karanikiotis H, Borrega Garcia P, Vukelja S, Northfelt D, Beck JT, Kozevnikovova R, Juhasz-Boess I, Geffen D, Karak FE, Zamora Aunon P, Hart L, Adams J, Santucci Alves da Silva B, Acevedo A, Christodoulou C, Mehta A, Pazzola A, Edlund P, Panwar U, Torrey M, Meyer A, Petzer A, Tournigand C, Heflik L, Mayer F, Gori S, Clement D, Shomova M, Law T, Horenkamp E, Rao R, Poncin R, Priester P, Baciuchka-Palmaro M, Mayeur D, Toledano A, Benasso M, Blasi L, Fujii T, Krie A, Pluard T, Cobb P, Kash J, Sanchez-Rivera I, McIntyre K, O'Rourke M, Mahmood T, Onwere I, Patel N, Zarwan C.

Author information

1: From Institut Gustave Roussy, INSERM Unité 981, Université Paris-Sud, Villejuif (F.A.), Institut de Cancérologie de l'Ouest, St. Herblain (M.C.), and Novartis Pharma, Paris (A.-S.L.) - all in France; Hospital Universitario 12 de Octubre, Madrid (E.C.); National Institute of Oncology (G.R.) and Duna Medical Center (Z.P.), Budapest, Hungary; German Breast Group, Neu-Isenburg, and Center for Hematology and Oncology Bethanien, Frankfurt - both in Germany (S.L.); UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco (H.S.R.); Aichi Cancer Center, Nagoya (H.I.), Kanagawa Cancer Center, Yokohama (T.Y.), Saitama Cancer Center, Saitama (K.I.), and National Hospital Organization Hokkaido Cancer Center, Sapporo (M.T.) - all in Japan; Istituto Oncologico Veneto and the Departments of Surgery, Oncology, and Gastroenterology, University of Padua, Padua, Italy (P.C.); Vanderbilt University, Nashville (I.A.M.); Chaim Sheba Medical Center, Tel Hashomer, Israel (B.K.); National Taiwan University Hospital, Taipei (Y.-S.L.); Novartis Pharma, Basel, Switzerland (D.M., C.W.); Novartis Pharmaceuticals, East Hanover, NJ (S.H.); and Massachusetts General Hospital Cancer Center, Boston (D.J.).

Abstract

BACKGROUND:

PIK3CA mutations occur in approximately 40% of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The PI3Kα-specific inhibitor alpelisib has shown antitumor activity in early studies.

METHODS:

In a randomized, phase 3 trial, we compared alpelisib (at a dose of 300 mg per day) plus fulvestrant (at a dose of 500 mg every 28 days and once on day 15) with placebo plus fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously. Patients were enrolled into two cohorts on the basis of tumor-tissue PIK3CA mutation status. The primary end point was progression-free survival, as assessed by the investigator, in the cohort with PIK3CA-mutated cancer; progression-free survival was also analyzed in the cohort without PIK3CA-mutated cancer. Secondary end points included overall response and safety.

RESULTS:

A total of 572 patients underwent randomization, including 341 patients with confirmed tumor-tissue PIK3CA mutations. In the cohort of patients with PIK3CA-mutated cancer, progression-free survival at a median follow-up of 20 months was 11.0 months (95% confidence interval , 7.5 to 14.5) in the alpelisib-fulvestrant group, as compared with 5.7 months (95% CI, 3.7 to 7.4) in the placebo-fulvestrant group (hazard ratio for progression or death, 0.65; 95% CI, 0.50 to 0.85; P<0.001); in the cohort without PIK3CA-mutated cancer, the hazard ratio was 0.85 (95% CI, 0.58 to 1.25; posterior probability of hazard ratio <1.00, 79.4%). Overall response among all the patients in the cohort without PIK3CA-mutated cancer was greater with alpelisib-fulvestrant than with placebo-fulvestrant (26.6% vs. 12.8%); among patients with measurable disease in this cohort, the percentages were 35.7% and 16.2%, respectively. In the overall population, the most frequent adverse events of grade 3 or 4 were hyperglycemia (36.6% in the alpelisib-fulvestrant group vs. 0.7% in the placebo-fulvestrant group) and rash (9.9% vs. 0.3%). Diarrhea of grade 3 occurred in 6.7% of patients in the alpelisib-fulvestrant group, as compared with 0.3% of those in the placebo-fulvestrant group; no diarrhea of grade 4 was reported. The percentages of patients who discontinued alpelisib and placebo owing to adverse events were 25.0% and 4.2%, respectively.

CONCLUSIONS:

Treatment with alpelisib-fulvestrant prolonged progression-free survival among patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously. (Funded by Novartis Pharmaceuticals; SOLAR-1 ClinicalTrials.gov number, NCT02437318.).

PMID:: 31091374
DOI:: 10.1056/NEJMoa1813904

Adding alpelisib to fulvestrant numerically improved mOS by 7.9 mo, though the result was not statistically significant. OS was numerically improved in hard-to-treat disease, including a 14-mo improvement in those with lung/liver metastases

Alpelisib Plus Fulvestrant for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-2–Negative Advanced Breast Cancer: Final Overall Survival Results From SOLAR-1

Open AccessPublished:November 24, 2020DOI:https://doi.org/10.1016/j.annonc.2020.11.011

Highlights

•
In SOLAR-1, the key secondary endpoint of OS was evaluated in patients with HR+, HER2–, PIK3CA-mutated ABC
•
Adding alpelisib to fulvestrant numerically improved mOS by 7.9 mo, though the result was not statistically significant
•
OS was numerically improved in hard-to-treat disease, including a 14-mo improvement in those with lung/liver metastases
•
Median time to first chemotherapy was delayed by 8.5 months with the addition of alpelisib to fulvestrant
•
With longer follow-up, the alpelisib plus fulvestrant safety profile was similar to prior reports with no new safety signals

ABSTRACT

Background

Activation of the phosphatidylinositol-3-kinase (PI3K) pathway via PIK3CA mutations occurs in 28%-46% of hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancers (ABC) and is associated with poor prognosis. The SOLAR-1 trial showed that the addition of alpelisib to fulvestrant treatment provided statistically significant and clinically meaningful progression-free survival (PFS) benefit in PIK3CA-mutated, HR+, HER2– ABC.

Patients and Methods

Men and postmenopausal women with HR+, HER2– ABC whose disease progressed on or after aromatase inhibitor (AI) were randomized 1:1 to receive alpelisib (300 mg/day) plus fulvestrant (500 mg every 28 days and once on Day 15) or placebo plus fulvestrant. Overall survival (OS) in the PIK3CA-mutant cohort was evaluated by Kaplan-Meier methodology and a 1-sided stratified log-rank test was performed with an O’Brien-Fleming efficacy boundary of P≤0.0161.

Results

In the PIK3CA-mutated cohort (n=341), median OS (95% confidence interval ) was 39.3 months (34.1-44.9) for alpelisib-fulvestrant and 31.4 months (26.8-41.3) for placebo-fulvestrant (hazard ratio = 0.86 [95% CI, 0.64-1.15; P=0.15]). Overall survival results did not cross the prespecified efficacy boundary. Median OS (95% CI) in patients with lung and/or liver metastases was 37.2 months (28.7-43.6) and 22.8 months (19.0-26.8) in the alpelisib-fulvestrant and placebo-fulvestrant arms, respectively (HR=0.68 [0.46-1.00]). Median times to chemotherapy (95% CI) for the alpelisib-fulvestrant and placebo-fulvestrant arms were 23.3 months (15.2-28.4) and 14.8 months (10.5-22.6), respectively (HR=0.72 [0.54-0.95]). No new safety signals were observed with longer follow-up.

Conclusions

Although the analysis did not cross the prespecified boundary for statistical significance, there was a 7.9-month numeric improvement in median OS when alpelisib was added to fulvestrant treatment for patients with PIK3CA-mutated, HR+, HER2– ABC. Overall, these results further support the statistically significant prolongation of PFS observed with alpelisib plus fulvestrant in this population, which has a poor prognosis due to a PIK3CA mutation.

References

- Di Leo A.
- Johnston S.
- Lee K.S.
- et al.
Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial.
Lancet Oncol. 2018; 19: 87-100
View in Article
Mollon L, Aguilar A, Anderson E et al. A systematic literature review of the prevalence of PIK3CA mutations and mutation hotspots in HR+/HER2– metastatic breast cancer. Presented at: American Association for Cancer Research Annual Meeting 2018; April 14-17, 2018; Chicago, IL. Abstract 1207.
View in Article
- Google Scholar
- Moynahan M.E.
- Chen D.
- He W.
- et al.
Correlation between PIK3CA mutations in cell-free DNA and everolimus efficacy in HR+, HER2- advanced breast cancer: results from BOLERO-2.
Br J Cancer. 2017; 116: 726-730
View in Article
- Cancer Genome Atlas Network
Comprehensive molecular portraits of human breast tumours.
Nature. 2012; 490: 61
View in Article
Tolaney S, Toi M, Neven P et al. Clinical significance of PIK3CA and ESR1 mutations in ctDNA and FFPE samples from the MONARCH 2 study of abemaciclib plus fulvestrant. Presented at: American Association for Cancer Research Annual Meeting 2019; March 29-April 3, 2019; Atlanta, GA. Abstract 4458.
View in Article
- Google Scholar
- Angus L.
- Smid M.
- Wilting S.M.
- et al.
The genomic landscape of metastatic breast cancer highlights changes in mutation and signature frequencies.
Nat Genet. 2019; 51: 1450-1458
View in Article
- Martinez-Saez O.
- Chic N.
- Pascual T.
- et al.
Frequency and spectrum of PIK3CA somatic mutations in breast cancer.
Breast Cancer Res. 2020; 22: 45
View in Article
- Mosele F.
- Stefanovska B.
- Lusque A.
- et al.
Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer.
Ann Oncol. 2020; 31: 377-386
View in Article
- Sobhani N.
- Roviello G.
- Corona S.P.
- et al.
The prognostic value of PI3K mutational status in breast cancer: a meta-analysis.
J Cell Biochem. 2018; 119: 4287-4292
View in Article
- Fritsch C.
- Huang A.
- Chatenay-Rivauday C.
- et al.
Characterization of the novel and specific PI3Kα inhibitor NVP-BYL719 and development of the patient stratification strategy for clinical trials.
Mol Cancer Ther. 2014; 13: 1117-1129
View in Article
Fritsch C, Pfister E, Ebel N et al. Determination of the PI3Kα selective inhibitor alpelisib mechanism of action and efficacy in ER+/PIK3CA mutant breast cancer pre-clinical models. Presented at: American Association for Cancer Research 2018 Annual Meeting; April 14-18; Chicago, IL. Abstract 3934.
View in Article
- Google Scholar
- André F.
- Ciruelos E.
- Rubovszky G.
- et al.
Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer.
N Engl J Med. 2019; 380: 1929-1940
View in Article
Juric D, Ciruelos EM, Rubovszky G et al. Alpelisib (ALP) + fulvestrant (FUL) for advanced breast cancer (ABC): phase 3 SOLAR-1 trial results. Presented at: San Antonio Breast Cancer Symposium; December 4-8, 2018; San Antonio, TX. Abstract GS3-08.
View in Article
- Google Scholar
- Furet P.
- Guagnano V.
- Fairhurst R.A.
- et al.
Discovery of NVP-BYL719 a potent and selective phosphatidylinositol-3 kinase alpha inhibitor selected for clinical evaluation.
Bioorg Med Chem Lett. 2013; 23: 3741-3748
View in Article
André F, Ciruelos EM, Rubovszky G et al. Alpelisib + fulvestrant for HR+, HER2– advanced breast cancer: Results of the phase III SOLAR-1 trial. Presented at: European Society for Medical Oncology Congress 2018; October 19-23, 2018; Munich, Germany. Abstract LBA3.
View in Article
- Google Scholar
- Juric D.
- Rodon J.
- Tabernero J.
- et al.
Phosphatidylinositol 3-kinase α–selective inhibition with alpelisib (BYL719) in PIK3CA-altered solid tumors: results from the first-in-human study.
J Clin Oncol. 2018; 36: 1291-1299
View in Article
- Juric D.
- Janku F.
- Rodón J.
- et al.
Alpelisib plus fulvestrant in PIK3CA-altered and PIK3CA-wild-type estrogen receptor–positive advanced breast cancer: a phase 1b clinical trial.
JAMA Oncol. 2019; 5e184475
View in Article
Rugo HS, Mayer IA, Conte P. Prevalence of PIK3CA Mutations in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-2-Negative Advanced Breast Cancer From the SOLAR-1 Trial. Presented at: American Association for Cancer Research Annual Meeting 2019; March 29-April 3, 2019; Atlanta, GA. Abstract CT142.
View in Article
- Google Scholar
- Rugo H.S.
- André F.
- Yamashita T.
- et al.
Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer.
Ann Oncol. 2020; 31: 1001-1010
View in Article
- Mosele F.
- Stefanovska B.
- Lusque A.
- et al.
Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer.
Ann Oncol. 2020; 31: 377-386
View in Article
- Cristofanilli M.
- Turner N.C.
- Bondarenko I.
- et al.
Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.
Lancet Oncol. 2016; 17: 425-439
View in Article
- Baselga J.
- Im S.A.
- Iwata H.
- et al.
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.
Lancet Oncol. 2017; 18: 904-916
View in Article
- Seidman A.D.
- Bordeleau L.
- Fehrenbacher L.
- et al.
National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer.
J Clin Oncol. 2018; 36: 3259-3268
View in Article
Rugo HS, Lerebours F, Ciruelos E. Alpelisib + Fulvestrant in Patients With PIK3CA-Mutated Hormone-Receptor Positive (HR+), Human Epidermal Growth Factor Receptor-2-Negative (HER2–) Advanced Breast Cancer (ABC) Previously Treated With Cyclin-Dependent Kinase 4/6 Inhibitor (CDKi) + Aromatase Inhibitor (AI): BYLieve Study Results. Presented at: Virtual American Society of Clinical Oncology 2020 Annual Meeting; May 29-31, 2020 (Abstract 1006).
View in Article
- Google Scholar
- Slamon D.J.
- Neven P.
- Chia S.
- et al.
Overall survival with ribociclib plus fulvestrant in advanced breast cancer.
N Engl J Med. 2020; 382: 514-524
View in Article
- Im S.-A.
- Lu Y.-S.
- Bardia A.
- et al.
Overall survival with ribociclib plus endocrine therapy in breast cancer.
N Engl J Med. 2019; 381: 307-316
View in Article
- Sledge G.W.
- Toi M.
- Neven P.
- et al.
The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy—MONARCH 2: a randomized clinical trial.
JAMA Oncol. 2019; 6: 116-124
View in Article
- Turner N.C.
- Slamon D.J.
- Ro J.
- et al.
Overall survival with palbociclib and fulvestrant in advanced breast cancer.
N Engl J Med. 2018; 379: 1926-1936
View in Article
Mayer IA, Rugo HS, Loibl S et al. Patient-reported outcomes in patients with PIK3CA-mutated hormone receptor-positive, human epidermal growth factor receptor-2–negative advanced breast cancer from SOLAR-1. Presented at: American Society of Clinical Oncology 2019 Annual Meeting; May 31-June 4; Chicago, IL. Abstract 1039.
View in Article
- Google Scholar