“Adjuvant therapy with gefitinib (Iressa), an epidermal growth factor receptor (EGFR)-targeted agent, was more successful at preventing recurrence than standard-of-care chemotherapy, in a phase III study of patients with EGFR-positive non–small cell lung cancer (NSCLC). Gefitinib extended recurrence-free survival by about 10 months in patients with stage II–IIIA NSCLC. These findings were presented at the 2017 ASCO Annual Meeting.”
“The targeted therapy gefitinib appears more effective in preventing recurrence after lung cancer surgery than the standard of care, chemotherapy. In a phase III clinical trial, patients with epidermal growth factor receptor (EGFR)-positive, stage II-IIIA non-small cell lung cancer (NSCLC) who received gefitinib went about 10 months longer without recurrence than patients who received chemotherapy. The study will be presented at the upcoming 2017 ASCO Annual Meeting in Chicago.
” ‘Adjuvant gefitinib may ultimately be considered as an important option for stage II-IIIA lung cancer patients with an active EGFR mutation, and we may consider routine EGFR testing in this earlier stage of lung cancer,’ said lead study author Yi-Long Wu, MD, a director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. ‘We intend to follow these patients until we can fully measure overall survival as opposed to disease-free survival, which just measures disease recurrence.’ ”
“The timing of surgery after neoadjuvant chemoradiation in patients with stage IIIA non-small cell lung cancer (NSCLC) affects the overall survival of patients receiving trimodality therapy.
“Approximately one third of all NSCLC patients have locally advanced (stage III, subtypes IIIA and IIIB) disease at the time of diagnosis, with a five-year survival ranging from 7 to 19%. Patients with stage III NSCLC represent a significant clinical challenge due to the poor prognosis associated with this stage of the disease. Trimodality therapy involving the use of radiation concurrently with chemotherapy, otherwise known as neoadjuvant chemoradiation therapy (NCRT), followed by surgery is an acceptable treatment strategy for stage IIIA patients with resectable tumors and limited mediastinal node (N2) involvement. However, trimodality therapy has not been shown to have significant survival advantage over definitive chemoradiation therapy and the optimal interval to surgery (ITS) after completion of NCRT has not been well explored.”
“Current guidelines from the National Comprehensive Cancer Network (NCCN) and American College of Chest Physicians (ACCP) recommend that operable patients with clinical Stage IIIA non-small cell lung cancer (NSCLC) should receive induction chemotherapy (with or without concurrent radiotherapy) followed by resection if there is no apparent progression of disease. While four quality measures have been identified as associated with improved overall survival, until now it has been unclear to what extent patients are actually receiving each of these measures as part of their care. A presentation at the 96th AATS Annual Meeting clearly demonstrates that survival rates increase as more quality measures are incorporated into patient care – but only 13% of eligible patients actually received all four measures.”
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“Erlotinib showed promise as neoadjuvant therapy in patients with epidermal growth factor receptor (EGFR) mutant stage IIIA-N2 non-small-cell lung cancer (NSCLC) who demonstrated good disease control with tolerable toxicity following treatment.
“Dr Baohui Han, Pulmonary Department, Shanghai Chest Hospital, Shanghai, China presented findings from a single arm, phase II clinical trial during the New Treatment Avenues Proffered Papers session at the European Lung Cancer Conference, 15 to 18 April 2015 in Geneva, Switzerland. The trial aimed to evaluate efficacy and safety of erlotinib as neoadjuvant treatment in patients with stage IIIA-N2 NSCLC and activating EGFR mutation.
“The trial’s primary endpoint was radical resection rate. Secondary endpoints included pathological complete response rate (pCR), objective response rate (ORR), disease free survival (DFS), overall survival (OS), safety profile, and explorative biomarkers.
“This study screened 155 patients and subsequently enrolled 44 patients with stage IIIA N2 NSCLC and 25 patients with IIIA N2 NSCLC plus activating EGFR (exon 19 or 21) mutations. All patients had ECOG performance status 1 and had been previously untreated for stage IIIA-N2 NSCLC, that was confirmed by endobronchial ultrasound.”
“A retrospective study found that early-stage non–small-cell lung cancer (NSCLC) patients over 70 years old derive a similar benefit as younger patients from adjuvant chemotherapy following surgical resection. This suggests that age should not preclude patients from receiving adjuvant chemotherapy.
“ ‘Studies conducted in the last decade have provided evidence that adjuvant chemotherapy after surgical resection improves outcomes for patients with resected stages II and IIIA disease and selected patients with stage I (large tumor size) NSCLC,’ wrote study authors led by Apar Kishor Ganti, MD, of the University of Nebraska Medical Center in Omaha. These studies, however, have not focused specifically on elderly patients, and NSCLC has a median age of 70 years at diagnosis.
“The new study was a population-based retrospective review of 7,593 patients with stage IB to stage III NSCLC who underwent surgical resection; 2,897 (38%) were aged at least 70 years. Results of the study were published online ahead of print in Cancer.
“Among the younger patients, 31.6% received adjuvant chemotherapy, while only 15.3% of the older patients received this treatment (P .0001). Both groups saw changes in rates of adjuvant chemotherapy over time, though of different magnitudes: 9.3% of younger patients diagnosed between 2001 and 2003 received adjuvant chemotherapy, which rose by 27.8% by 2009 to 2011. In older patients, the rate was 4.5% in the earlier period and increased by 16.0%. The most common chemotherapy option used in all patients (64.6%) was carboplatin-based doublets.”
The gist: An attempt to improve treatment for stage III non-small cell lung cancer (NSCLC) patients failed when it was tested in a clinical trial. People with stage III NSCLC are normally treated with radiation and chemotherapy. Researchers wondered if giving higher-dose radiation or adding the drug cetuximab (Erbitux) would improve the standard treatment. However, when tested in patients, neither approach worked better than the standard approach.
“As reported in The Lancet Oncology by Bradley and colleagues, the phase III Radiation Therapy Oncology Group 0617 trial showed no survival benefit of high- vs standard-dose radiotherapy or for addition of cetuximab (Erbitux) to concurrent paclitaxel-carboplatin chemoradiation in patients with inoperable stage IIIA or IIIB non–small cell lung cancer (NSCLC).
“In the open-label 2×2 factorial trial, patients from the United States and Canada were randomly assigned 1:1:1:1 between November 2007 and November 2011 to receive 60 Gy radiotherapy (n = 166), 74 Gy radiotherapy (n = 121), 60 Gy radiotherapy and cetuximab (n = 147), or 74 Gy radiotherapy and cetuximab (n = 110) with all patients receiving concurrent once-weekly chemotherapy with paclitaxel at 45 mg/m2 and carboplatin at area under the curve (AUC) 2. Two weeks after chemoradiation, patients received two cycles of consolidation paclitaxel at 200 mg/m2 and carboplatin at AUC 6 separated by 3 weeks. Radiation was given in 2-Gy daily fractions with either intensity-modulated or three-dimensional conformal radiation therapy. Cetuximab was given at 400 mg/m2 on day 1 followed by 250 mg/m2 weekly continued through consolidation therapy. The primary endpoint was overall survival.
“Patients had a median age of 64 years, and most were male (55%–64%), white (82%–89%), had Zubrod performance status of 0 (55%–59%), were current smokers (43%–51%), received three-dimensional conformal radiotherapy (47%–54%), underwent positron-emission tomography (PET) staging (89%–91%), had squamous histology (42%–47%), and had stage IIIA disease (63%–66%).”
The gist: People with stage IIIA N2 non-small cell lung cancer (NSCLC) whose tumors are completely removed by surgery might benefit from radiation treatment to the head. This treatment is called prophylactic cranial irradiation (PCI). It is meant to prevent brain metastases. PCI was tested in patients in a recent clinical trial. Patients who had PCI after surgery went for longer without signs or symptoms of their cancer than patients who did not have PCI. PCI also prevented brain metastases for these patients.
“Prophylactic cranial radiation significantly extended DFS compared with observation in patients with fully resected stage IIIA-N2 non–small cell lung cancer, according to results of an open-label, randomized phase 3 trial.
“Prophylactic cranial radiation (PCI) also decreased incidence of brain metastases in that same patient population, results showed.
“The analysis included 156 patients with fully resected, postoperative pathologically confirmed stage IIIA-N2 NSCLC at high risk for cerebral metastases. Patients underwent postoperative adjuvant chemotherapy without recurrence.
“Ning Li, MD, of the department of thoracic surgery at Sun Yat-sen University Cancer Center in China, and colleagues randomly assigned 81 patients to PCI (30 Gy in 10 fractions). The other 75 patients were assigned to observation.
A series of three new clinical trials (research studies with volunteer patients) is big news for some people affected by early-stage lung cancer. The trials focus on two drugs typically used to treat late-stage adenocarcinoma. These two drugs, Tarceva and Xalkori, may also help stage I, II, and IIIA patients prevent relapse (return of cancer) after their tumors have been surgically removed. The new clinical trials will put the treatments to the test. Continue reading…