Author Archive

PARSIFAL Study Status

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We are thrilled to announce that follow-up of patients participating in PARSIFAL study has been extended one year in order to meet the study efficacy criteria. End of study was initially planned at the end of 2018.

This is a randomized, multicentre, open-label, phase II trial to evaluate the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2 negative, ER+ metastatic breast cancer. The primary efficacy end point is progression free survival and final analysis will be performed at 254 events with 486 patients included.

50 sites from seven countries are participating in this study (Spain, France, UK, Germany, Italy, Czech Republic and Russia) and the number of patients randomized is 486. Recruitment started in July 2015 and there are currently 209 patients ongoing and 276 patients that have completed treatment.

From MedSIR, we would like to thank all patients, their families and study investigators for their participation in the study. Another special thanks is for Pfizer and Astra Zeneca for their continuous support. We are confident that results of Parsifal trial could contribute to improve treatment decisions to cancer patients.

PALMIRA study Poster Presentation at ESMO 2019 Congress

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The abstract of PALMIRA study was presented in a Poster Display Session at the ESMO 2019 Congress in Barcelona, Spain. PALMIRA poster was presented on Sunday, 29 of September 2019. Dr. Antonio Llombart, first author of the abstract and Principal Investigator, and MedSIR team was there to discuss PALMIRA study with other participants and with the session Chair.

PALMIRA is an international, multicenter, randomized, open-label, phase II clinical trial with the objective to evaluate the efficacy and safety of continuation of palbociclib in combination with second-line endocrine therapy (fulvestrant or letrozole) in hormone receptor-positive/HER2-negative Advanced Breast Cancer patients who have achieved clinical benefit during first-line palbociclib-based treatment.

The combination of a CDK4/6 inhibitor with letrozole or fulvestrant is the most active first-line treatment for patients with HR[+]/HER2[‐] advanced breast cancer. Although endocrine sensitivity persists beyond progression, preliminary findings suggest more adaptive resistance mechanisms to endocrine therapy than to CDK4/6 inhibitor. At present, there are no data about prolonging CDK4/6 blockade beyond progression on a CDK4/6 inhibitor.

The aim of this study is to determine whether palbociclib rechallenge combined with second-line endocrine therapy upon progression to a prior palbociclib–based therapy will improve progression-free survival over endocrine therapy alone in HR[+]/HER2[‐] advanced breast cancer patients.

A total of 198 patients will be randomized in a 2:1 ratio to palbociclib plus endocrine therapy (Arm A, N=132) or endocrine therapy alone (Arm B, N=66), until progressive disease or unacceptable toxicity. Patients previously treated with fulvestrant will change to letrozole treatment, and those previously treated with letrozole, anastrozole or exemestane will switch to fulvestrant treatment.

Currently, the PALMIRA trial is open and recruiting in France, Spain, and the United Kingdom. The patient recruitment started in April 2019.

We thank all participating patients and study team involved in PALMIRA trial.

PALMIRA Poster ESMO 2019

MedSIR at ESMO 2019

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The European Society for Medical Oncology (ESMO), founded in 1975, aims at advancing medical oncology on a pan-European basis. ESMO is the leading professional organization for medical oncology, with the overarching goal of improving outcomes for cancer patients everywhere. The ESMO’S 2019 annual meeting will take place in our hometown, Barcelona (Spain) from September 27th to October 1st, and MedSIR will be happy to attend once more!

The main topics of this year’s congress will focus on the last advances in oncology regarding diagnosis, treatment and patient care. The ESMO Congress is the appointment in Europe for clinicians, researchers, patient advocates, journalists and the pharmaceutical industry from all over the world to get together, learn about the latest advances in oncology and translate science into better cancer patient care.

MedSIR will take advantage of this unique opportunity not only to communicate the latest knowledge we have helped generate in the field, but also to maintain and establish new collaborations with key players in international oncologic research, expanding the scope of our focus from breast cancer to many other tumor types, and promoting the connections needed to further our goal of advancing clinical research in oncology.

Whether you are a patient, a clinician, or are representing a company, we would be thrilled to get in touch with you in order to see how we can collaborate together in improving the lives of cancer patients worldwide. We are looking forward to meeting you all in Barcelona!

Publication of TRASTYVERE Clinical Trial

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A retrospective, multicenter study of the efficacy of lapatinib plus trastuzumab in HER2 positive metastatic breast cancer patients previously treated with trastuzumab, lapatinib, or both: the TRASTYVERE study.

Targeting the human epidermal growth factor receptor 2 (HER2)-mediated signaling cascade with monoclonal antibodies or tyrosine kinase inhibitors was shown to be synergistic with cytotoxic agents and modified the natural history of HER2-positive breast cancer.

In the metastatic breast cancer scenario, maintenance of an anti-HER2 blockade over several lines of treatment has been proven to be clinically meaningful. In the first- and second-line, pertuzumab and trastuzumab-emtansine (T-DM1) were shown to be the more active options.

Multiple options are recommended after pertuzumab and T-DM1, including combinations with trastuzumab and lapatinib. On the other hand, the clinical activity of lapatinib after lapatinib and/or trastuzumab is currently unknown.

We designed this observational and retrospective study to evaluate the effectiveness in a real-world scenario of the lapatinib–trastuzumab combination in patients with HER2-positive metastatic breast cancer previously treated with lapatinib and/or trastuzumab.

Our study, which included 115 patients from 14 Spanish institutions, supports the hypothesis that combining the trastuzumab–lapatinib anti-HER2 agents is a safe and active chemotherapy-free option, even for patients who have previously failed to respond to prior lapatinib- and trastuzumab-based regimens.

It was a journey with many challenges, but the perseverance and effort of the site investigators and collaborators –as well as the MedSIR Operations team– were key in delivering these results. On behalf of MedSIR, we would like to thank all the patients who have participated in the TRASTYVERE trial as well as their families and support groups.

This retrospective, longitudinal, multicenter and observational study was designed and sponsored by MedSIR and funded by GlaxoSmithKline plc (GSK).

The publication in the Clinical Translational Oncology journal was accepted.

WCLC 2019 Highlights

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From September 7th to September 10th, MedSIR attended the 20th World Conference of Lung Cancer (WCLC), organized by the International Association for the Study of Lung Cancer (IASLC). This year’s edition of the world’s largest international gathering of clinicians, researchers and scientists in the field of lung cancer and thoracic oncology was celebrated in MedSIR’s hometown, Barcelona!

The conference was a great opportunity to present the most recent advances in lung cancer clinical research. Good news included an update of results presented at ASCO 2019 confirming the high activity of AMG510 in patients with non-small cell lung cancer (NSCLC) harboring the G12C KRAS mutation (around 13% of NSCLC patients). Although it’s still early to celebrate, this could imply the arrival of a new targeted therapy for patients that have had no effective treatments available so far.

Additional good results with targeted therapies, including selpercatinib for RET-fusion-positive NSCLC and larotrectinib for KTRK-fusion-positive NSCLC were also communicated. Regarding small cell lung cancer (SCLC), the first reported results of the CASPIAN trial with durvalumab confirmed the role of immunotherapy combined with chemotherapy as the new standard of care for frontline treatment of the disease.

All these advances increase the percentage of lung cancer patients which are candidate to novel, more effective treatments. But the WCLC 2019 congress was also highly focused on early detection, a crucial strategy in its own right to decrease the burden of the disease worldwide. New studies highlighting the potential of early screening to reduce mortality were presented during the conference, and a renewed international push to apply this strategy is to be expected in the near future.

The venue also served as the perfect meeting point between researchers, industry members, patients and clinicians from all around the world. At MedSIR, we used this opportunity to generate new contacts and to advance the development of clinical research projects which we expect will also contribute to bring hope to people with lung cancer and to their caregivers worldwide. See you all next year in Singapur for the WCLC 2020 conference!