ABSTRACT
Background: Molecular tissue testing in non?small cell lung cancer (NSCLC) is done for the assessment of epidermal growth factor receptor (EGFR) mutation. EGFR mutation status is the basis for deciding the targeted treatment option for patients with metastatic NSCLC. The nonavailability of tissue samples and contraindications for biopsy pose a significant challenge. Hence circulating tumor DNA (ctDNA) by liquid biopsy can be a viable alternative for NSCLC patients. Methods: This study was conducted at 15 sites across India. EGFR mutation testing from plasma was done as part of the study at the central laboratory by the next?generation sequencing (NGS) method and EGFR mutation test results from tissue samples (done as part of routine practice) were recorded for all the patients. Results: Out of the total patients enrolled (N = 245) the majority (64.5% n = 158) were men. The median age of patients was 58.0 (range: 26�) years. The concordance between plasma and tissue testing was found to be 82.9% (95% confidence interval [CI]: 77.55 87.45). The sensitivity and specificity of NGS were 68.4% (95% CI: 56.92 78.37) and 90.1% [95% CI: 84.36 94.21) respectively. Plasma testing detected 1.2% (n = 3) and tissue sample testing detected 2.4% (n = 6) positive status of exon 20 T790M EGFR mutation. Out of the total number of patients enrolled 25 were tissue positive and plasma negative while 16 were plasma positive and tissue negative. Conclusions: This real?world study in Indian patients suggests that plasma testing for EGFR mutation analysis is a viable diagnostic option in newly diagnosed advanced/metastatic NSCLC patients. The noninvasive plasma procedure in patients without available/evaluable tumor sample may enable more patients to receive appropriate targeted therapies by providing clinicians with valuable insights into the patient抯 tumor mutation status. ClinicalTrials.gov Identifier: NCT03562819
ABSTRACT
Technological advances in radiation beam planning and linear accelerator based radiation delivery have led to the development of three dimensional conformal radiation therapy (3D-CRT). The 3D-CRT clinical treatment in our hospital was started in September 1998 and till December 2002, 51 patients with M(0) stage prostate carcinoma were treated. Treatment method consisted of pelvis and leg immobilization, planning CT scan, marking of planning target volume and organs at risk and 3D beam plan using multileaf collimated beam shaping through beam's eye view display. Network controlled 3D conformal radiation therapy was delivered with portal image verification. The median 3D-CRT dose was 72 Gy. Of the 51 patients, 35 were followed-up till December 2002 (minimum follow-up 2 years) in whom 32 were disease free and 3 had progressive disease. Eleven patients died, 8 of progressive disease, one due to second malignancy and two of intercurrent illness. Five patients were lost for follow up during 0 - 29 months period, after 3D-CRT. The acute rectal reaction (RTOG criteria) in 51 patients was grade 0 in 4, grade I in 31 and grade II in 16. None had greater than grade II rectal toxicity. The late rectal toxicity in 49 patients who had a minimum 6 months follow-up was grade 0 in 41, grade I in 3 and grade II in 5. Our experience suggests that a dose of 72 Gy by 3D-CRT can be safely delivered to the prostate and gastrointestinal tolerance during treatment and follow-up period was excellent.