Finding treatment strategies that provide a cure for patients without utilizing toxic treatments, and thus improving their quality of life, is a major clinical need. The PHERGain trial, sponsored and designed by MEDSIR, has been carried out under the so-called therapeutic de-escalation strategy, consisting of eliminating chemotherapy, without a negative impact on the patient's prognosis.
This is the first trial to be performed in patients with localized HER2-positive breast cancer with a strategic design, which consists of gradually adapting the treatment of each patient based on the therapeutic response observed. Preliminary results of this study were presented in May 2020 at the 56th Congress of the American Society of Clinical Oncology (ASCO) and the impact of the final results has permitted the publication in The Lancet Oncology journal.
This phase II clinical trial has involved researchers from 45 centers located in seven European countries (Spain, France, Belgium, Germany, the United Kingdom, Italy, and Portugal) and has recruited a total of 356 patients with localized HER2-positive breast cancer, randomized to receive either trastuzumab and pertuzumab with chemotherapy (Group A, 71 patients) or without chemotherapy (Group B, 285 patients), respectively. All patients underwent an imaging test with PET-CT after two treatment cycles to timely observe the tumor response. The results of both the PET-CT imaging test and the pathological response (disappearance of the tumor at the moment of surgery) determined the treatment regimen of patients in Group B.
PHERGain provided evidence that the PET-CT imaging test could identify around 40% of patients with localized HER2-positive early breast cancer who might not require chemotherapy. Results also clearly showed that patients that did not receive chemotherapy had a better toxicity profile and reduced impact on quality of life compared with patients who received chemotherapy.
In relation to the observed findings, Javier Cortés, one of the senior co-authors of PHERGain publication, has highlighted that “This PET-CT–based pathological response–adapted strategy could provide useful information to identify patients who might not require chemotherapy, with a subsequent improvement in their quality of life”.
Although such a strategy will require further clinical investigation, the PHERGain study offers a potential future therapeutic option for this patient population.
Don’t hesitate to contact us for further information about this trial or any of our ongoing trials.
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