J BUON. 2013 Jan-Mar;18(1):188-94.

Phase II study of erlotinib plus gemcitabine in first-line treatment of poor prognosis, advanced non-small cell lung cancer patients.

Grigorescu AC, Bala C.

Department of Medical Oncology, Prof. Dr. Alexandru Trestioreanu Oncology Institute, Bucharest, Romania. alexgrigorescu2004@yahoo.com



PURPOSE: The purpose of the present trial was to investigate whether clinical benefit can be obtained by concurrent administration of erlotinib with gemcitabine as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) and ECOG performance status (PS) 2.

METHODS: Included were chemotherapy-naive patients with histologically/cytologically documented unresectable advanced and/or metastatic (stage IIIB/IV) NSCLC and ECOG PS 2. In this phase II, single-arm study, all patients received first-line gemcitabine plus erlotinib for 6 cycles or until disease progression, unacceptable toxicity or patient withdrawal due to any reason. The primary study objectives were the evaluation of disease response and the time to progression. Secondary objectives included evaluation of overall survival and the safety profile of gemcitabine plus erlotinib.

RESULTS: Nineteen eligible patients were studied. The overall response rate (complete response/CR and partial response7sol;PR) was 15.8% and the clinical benefit rate (CR+PR+stable disease sol;SD) 36.84%.The median overall survival for the whole study group was 39 weeks (95% CI 27-51) and the median time to disease progression for 19 evaluable patients was 15 weeks (95% CI 7-36). The safety profile of the combination was acceptable with only 2 serious adverse events.

CONCLUSION: Taking into account similar published clinical studies we conclude that gemcitabine plus erlotinib achieve superior response rate and comparable overall survival with acceptable toxicity compared to monochemotherapy with gemcitabine. This combination represents a treatment option for patients with advanced NSCLC and ECOG PS 2.

PMID: 23613405



Phase II study of erlotinib plus gemcitabine in first-line treatment of poor prognosis, advanced non-small cell lung cancer patients, 3 years later

Alexandru Calin Grigorescu

Senior research degree I, MD, PhD

Our results regarding the use of gemcitabine plus erlotinib in the treatment of patients with advanced NSCLC and poor performance status could be and now the basis for a therapeutic option. The response rate of 15.8% and clinical benefit rate of 36.84% are, in our opinion is resonable for this kind of patients. Of course the new tyrosinekinase inhibitors (TKIs) of second  generation and use of multiple larger scale of genetic testing have changed the vision of first-line and second  or third line therapy of NSCLC.

At the beginning of therapy with TKIs, treatment indication was established based on clinical factors. Also based on clinical elements and previous experiences, derived from observations on treatment with chemotherapeutic agents, was intuited and primary and secondary resistance to TKIs.

In the era of personalized medicine genetic determination (EGFR) brought a safer and quicker response estimate to TKIs for patients with NSCLC. Equally identification of genes such as T790M has become useful for diagnosis of resistance de novo or acquired.

In general, so-called targeted therapy is nowadays indication for patients who have a certain gene mutation indicates a significant response rate. Use of TKIs as first-line therapy is now enshrined in most treatment guidelines. From clinical experience with the use of erlotinib found that introduction of this therapeutic agent any time (line I, II, III and even IV) leads to an increase in survival.

The use of chemotherapy after TKIs in patients who responded to erlotinib has also resulted in obtaining a therapeutic response and increased survival. This makes sense because it is known that EGFR mutation is predictive of response to chemotherapy.

With all the new discoveries aspects of our study results remain valid one of them is the possibility of acquired resistance to TKIs reversion after administration of chemotherapy. Optimal combination and sequence to the chemotherapy and TKIs has not yet been fully clarified. Using genetic testing packages homeland is the path that will clarify the optimal use of TKIs. The trials of cost effective as other types of health economic studies will guide us for the most effective tests and therapies and from the economic point of view.

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