Randomized, Phase III Study of Gemcitabine or Erlotinib Maintenance Therapy Versus Observation, With Predefined Second-Line Treatment, After Cisplatin-Gemcitabine Induction Chemotherapy in Advanced Non–Small-Cell Lung Cancer

Pérol, Maurice; Chouaïd, C.; Pérol, David; Barlési, Fabrice; Gervais, Radj; Westeel, Virginie; Créquit, Jacky; Léna, H.; Vergnenègre, A.; Zalcman, Gérard; Monnet, I.; Caer, H. Le; Fournel, P.; Falchero, L.; Poudenx, M.; Vaylet, F.; Ségura-Ferlay, Céline; Devouassoux‐Shisheboran, Mojgan; Tarón, Miquel; Milleron, B.

doi:10.1200/jco.2011.39.9782

Cited by 206 publications

(160 citation statements)

References 32 publications

(16 reference statements)

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“…In the present study, the survival of all consecutive NSCLC patients in daily practice was evaluated, therefore, the study included ʻunfitʼ patients, who are usually excluded from clinical trials. However, it was notable that the OS time in these patients was not shorter than that observed in recent clinical trials (25)(26)(27)(28)(29)(30). In addition, in the present patients treated with platinum and pemetrexed, the OS time was as long as that observed in the PARAMOUNT trial (16.9 months) (31).…”

Section: Recently Mandrekar Et Alcontrasting

confidence: 46%

Similar survival benefits of a good response and stable disease to platinum-based chemotherapy in non-small cell lung cancer

et al. 2015

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Abstract. The present study aimed to evaluate the similar survival benefits of a good response [complete response or partial response (CR/PR)] and stable disease (SD) to chemotherapy in non-small cell lung cancer (NSCLC) patients in clinical practice. All 322 patients who were treated between 1999 and 2012 with first-line platinum-based chemotherapy were retrospectively analyzed. Tumor responses were classified according to the response evaluation criteria for solid tumors. A total of 67 (20.8%) patients experienced CR/PR and 165 (51.2%) achieved SD. There was no difference in progression-free survival between the patients with CR/PR and those with SD (P= 0.347). There was also no difference between the two groups with regard to overall survival time (P= 0.878). In multivariate analysis, disease-control (more than SD) was one of the favorable prognostic factors. In clinical practice, a survival benefit would be provided not only for the patients who have good response, but also for those with SD. IntroductionThe incidence and mortality rates of lung cancer have increased globally during the last few decades (1,2). The majority of cases of lung cancer diagnosed were non-small cell lung cancer (NSCLC), and ~40% of patients with NSCLC are affected by advanced diseases (3). For patients with advanced NSCLC with a good performance status, systemic chemotherapy is the standard therapy at present. The first-line treatment for such patients is platinum-based chemotherapy, which improves symptom control, quality of life and survival as compared with best supportive care (4). A good response [complete response or partial response (CR/PR)] to chemotherapy has typically been equated with the clinical benefit of increased survival (5), but only 20-30% of patients achieve a good response in previous clinical trials, while 40-50% maintain a stable disease (SD) status (6-8). Certain previous studies reported that an initial good response and stable disease indicate similar survival benefits for chemotherapeutical patients with advanced NSCLC (9,10). The present retrospective study was undertaken to evaluate the similar survival benefits of a good response and stable disease to platinum-based chemotherapy in previously untreated NSCLC patients. Patients and methodsPatients. The patients enrolled in the present study were those consecutively diagnosed with NSCLC and treated with platinum-based chemotherapy as first-line treatment at the University of Tsukuba Hospital and Tsukuba Medical Center Hospital (both Tsukuba, Ibaraki, Japan) between January 1999 and December 2012. All the patients were histologically/cytologically confirmed as presenting with NSCLC and unresectable advanced disease. The histopathological diagnosis was defined by the World Health Organization classification (11), and patients were staged according to the Union for International Cancer Control tumor-node-metastasis system (12). Treatment and response.Enrolled patients received at least one cycle of cisplatin-or carboplatin-based chemotherapy. The clinical, ...

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Section: Recently Mandrekar Et Alcontrasting

confidence: 46%

Similar survival benefits of a good response and stable disease to platinum-based chemotherapy in non-small cell lung cancer

et al. 2015

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“…[30] Moreover, gemcitabine maintenance treatment was only a useful treatment option for lung cancer patients with good performance status and patients who demonstrated an objective response to platinum-gemcitabine. [31] So, possible response rate is low and benefit is insufficent for patients who presented stable disease following the first-line chemoterapy for lung cancer. Thus, parameters predicting the benefit of maintenance therapy gain importance for the proper selection of maintenance treatment, best supportive care or second-line chemotherapy for many cancer types.…”

Section: Discussionmentioning

confidence: 99%

Maintenance treatment with gemcitabine have a promising activity on metastatic bladder cancer survival

Kuş

Aktaş

2017

Turkish Journal of Urology

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Objective: To investigate the effects of gemcitabine maintenance treatment on survival in patients with metastatic bladder cancer. Material and methods:Gemcitabine maintenance monotherapy was administered following the standard platinum-gemcitabine therapy in patients with metastatic bladder cancer. Patients who had responded to standard treatment received maintenance gemcitabine therapy as 1000 mg/m 2 on days 1 and 8 every three weeks until progression or development of unacceptable toxicity. The following clinical factors were noted: performance status, age, sex, stage, site of metastasis, choice of cisplatin-gemcitabine or carboplatin-gemcitabine, response rates to the initial chemotherapy. Progression-free survival (PFS) and overall survival (OS) for standard treatment, and following gemcitabine monotreatment and for maintenance gemcitabine therapy were calculated using Kaplan-Meier method.Results: A total of 88 patients with metastatic bladder cancer treated between February 2009 to October 2015 were evaluated retrospectively and 23 patients (26.1%) who had responded to six cycles of platinumgemcitabine treatment were included in this study. Maintenance gamcitabine was administered for a median of 7 times (range 3-14 times). Grade 3 hematotoxicity according to the criteria of the Common Terminology Criteria of Adverse Events was observed in 7 (30.4%) patients. Median PFS of patients was 46 (range: 30-82) weeks for platinum-based treatment plus maintenance gemcitabine therapy. A higher median PFS was obtained in patients who were <65 year-olds, without organ metastasis with objective response rate, however, it was statistically insignificant. Conclusion:Gemcitabine maintenance therapy in metastatic bladder cancer patients who did not shown progression after the standard platinum-gemcitabine treatment contributes to survival and presents low toxicity profile, when compared to historical controls.

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“…Other trials have shown improvements in PFS (but not OS) for maintenance. Docetaxel (Fidias et al [15]) or gemcitabine (CECOG and IFCT-GFPC 0502 trials [36,37]) could also be considered, especially for patients with squamous NSCLC tumors.…”

Section: Optimal Maintenance Strategy: Which Is Best?mentioning

confidence: 99%

Complex Decisions for First-Line and Maintenance Treatment of Advanced Wild-Type Non-Small Cell Lung Cancer

Gentzler

Johnson

2015

The Oncologist

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Until recently, the first-line treatment of advanced non-small cell lung cancer (NSCLC) required minimal clinical decision making. Patients who were eligible for chemotherapy received a platinum-based doublet, and 5-year survival rates were poor. With the advent of molecularly targeted agents and better tolerated chemotherapies-namely, bevacizumab, erlotinib, and pemetrexed-new therapeutic opportunities have emerged. Some of the strategies that have proven to be successful for the treatment of patients with NSCLC are targeting of the vascular endothelial growth factor, use of maintenance chemotherapy for patients without progression of disease after initial therapy, and tailoring of cytotoxic agents specific to the histology of an individual patient's cancer. Each approach has been independently shown to improve overall survival, but integrating the data from a number of complicated trialsintothe"best"approach for patients remains challenging. This review attempts to address three fundamental questions clinicians face in choosing first-line and maintenance treatment for advanced NSCLC, particularly nonsquamous histology: Is pemetrexed or a taxane agent better for combination with platinum therapy? Should bevacizumab be used, and is it beneficial when added to pemetrexed chemotherapy? When is maintenance therapy indicated, and which agent is best? The Oncologist 2015;20:299-306

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Randomized, Phase III Study of Gemcitabine or Erlotinib Maintenance Therapy Versus Observation, With Predefined Second-Line Treatment, After Cisplatin-Gemcitabine Induction Chemotherapy in Advanced Non–Small-Cell Lung Cancer

Abstract: Gemcitabine continuation maintenance or erlotinib switch maintenance significantly reduces disease progression in patients with advanced NSCLC treated with cisplatin-gemcitabine as first-line chemotherapy. Response to induction chemotherapy may affect OS only for continuation maintenance.

Cited by 206 publications

References 32 publications

Similar survival benefits of a good response and stable disease to platinum-based chemotherapy in non-small cell lung cancer

Similar survival benefits of a good response and stable disease to platinum-based chemotherapy in non-small cell lung cancer

Maintenance treatment with gemcitabine have a promising activity on metastatic bladder cancer survival

Complex Decisions for First-Line and Maintenance Treatment of Advanced Wild-Type Non-Small Cell Lung Cancer

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