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Digambar Behera
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MA 03 - Chemotherapy (ID 651)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:Jin-Hyoung Kang, W. Su
- Coordinates: 10/16/2017, 11:00 - 12:30, Room 502
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MA 03.02 - Timing of B12/Folate Supplementation in NSCLC Patients on Pemetrexed Based Chemotherapy: Final Results of the PEMVITASTART Randomized Trial (ID 7957)
11:05 - 11:10 | Author(s): Digambar Behera
- Abstract
- Presentation
Background:
Vitamin B12 and folic acid supplementation(B12-FAS) reduces the incidence and severity of hematological toxicity[HTox] in pemetrexed-based chemotherapy. It is recommended to initiate B12-FAS 5-7 days before the first cycle. Observational and prospective single-arm studies have not shown any increase in HTox when pemetrexed was started earlier than the recommended duration of B12-FAS.
Method:
An open-label, randomized trial (PEMVITASTART; NCT02679443) was conducted to evaluate differences in HTox between patients initiated on pemetrexed-platinum chemotherapy following 5-7 days of B12-FAS (Delayed Arm; DA) versus those receiving B12-FAS simultaneously(≤24 hours) with chemotherapy initiation (Immediate Arm; IA). Eligible patients had locally advanced/metastatic non-squamous NSCLC AND ECOG PS=0-2. Block randomization was 1:1 into DA and IA. All enrolled patients received 3-weekly pemetrexed-platinum doublet [500mg/m[2] AND cisplatin(65mg/m[2]) OR carboplatin(AUC 5.0mg/mL/min) each on D1] for maximum of six cycles. Supplementation was 1000µgm FA PO daily and 3-weekly 1000µgm i/m vitamin B12. Primary outcome was any grade HTox while secondary outcomes were grade 3/4 HTox, relative dose intensity(RDI) delivered, inter-cycle delays(ICDs), supportive therapies usage (ESA/G-CSF/PRBC transfusions) and changes in serum levels of B12/FA/homocysteine.
Result:
Of 161 patients recruited (81 IA, 80 DA), 150 patients (77 IA, 73 DA) received ≥1 cycle and were included in modified ITT analysis. Baseline parameters were matched except for gender (IA=10.4%, DA=23.3%, p=0.03) and baseline thrombocytopenia (IA=7.8%, DA=0%, p=0.03). Baseline anemia(Hb<12gm/dL) was present in 34.7% (IA=32.5%, DA=37.0%; p=0.56). Incidence of any grade anemia, leukopenia, neutropenia and thrombocytopenia was 87.0% vs. 87.7%(p=0.90), 37.7% vs. 28.8%(p=0.25), 20.8% vs. 15.1%(p=0.36) and 31.2% vs. 16.4%(p=0.04) in IA and DA respectively. Grade 3/4 anemia was 18.2% vs. 12.3%(p=0.32) in IA and DA respectively while other cytopenias were similar (<5% in each arm). Supportive therapies usage in IA vs. DA were 22.1% vs. 12.3% for PRBC transfusions (p=0.12), 3.9% vs. 6.8% for G-CSF (p=0.49) and 10.4% vs. 1.4% for ESAs (p=0.03). ICDs occurred in 14.3% of IA vs. 8.2% in DA (p=0.24). RDI delivered (median 93.5% for pemetrexed and 91.0% for platinum) was similar in both arms. Following continued B12-FAS, after C3(compared to baseline), serum homocysteine was lower (median 10.0µmol/L vs. 17.6µmol/L;p<0.001) while FA (median 17.9ng/ml vs. 5.7ng/ml;p<0.001) and B12 levels (mean 1926.3pg/ml vs. 880.2pg/ml;p<0.001) were higher. In DA, serum FA and B12 on Day1 of C1(following 5-7days of B12-FAS) were significantly higher than baseline but homocysteine levels were similar.
Conclusion:
Simultaneous B12-FAS initiation with pemetrexed-based chemotherapy is feasible with acceptable HTox profile. Serum homocysteine levels are unaffected by 5-7 days of B12-FAS.
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-018 - Effectiveness of Supportive Care Drugs in Lung Cancer Patients Undergoing 1st Line Chemotherapy in a Resource Limited Setting (ID 7895)
09:30 - 09:30 | Presenting Author(s): Digambar Behera
- Abstract
Background:
Lung cancer(LC) chemotherapy is associated with several adverse effects(AEs). Data regarding supportive care medications(SCMs) offered to prevent/treat chemotherapy-related AEs in resource-limited settings and compliance to these therapies is lacking. A prospective observational study was therefore carried out in an attempt to ascertain effectiveness of SCMs in real life setting.
Method:
Consecutive patients with newly-diagnosed LC initiated on first-line chemotherapy at a tertiary referral centre in North India (from July 2014-September 2015) were enrolled. Details of chemotherapy-related AEs including incidence, timing of onset, duration and grades were recorded. Compliance with use of mandatory SCMs prescribed after each chemotherapy cycle was assessed by a structured questionnaire. Patients were also instructed to maintain a symptom diary to record various symptoms, frequency of use of need-based SCMs, visits to local health-care providers and hospitalization(if any) during the inter-cycle period.
Result:
Of 112 patients enrolled, majority were males(83.9%,n=94), current/ex-smokers(82.1%,n=92), had advanced stage [IIIB=33.9%(n=38), IV=46.4%(n=52)] and of non-small-cell type (NSCLC; 72.3%,n=81). A total of 602 chemotherapy cycles were administered with AEs being reported in 580 cycles(96.3%). Diarrhea was the commonest AE(180 cycles,29.9%) developing after a mean (SD) duration of 3.6(2.5) days and lasting for 4(3.3) days. Vomiting(138 cycles,22.9%) beginning after a mean (SD) of 3.5(2.7) days, lasting for 3.8(3.1) days; and constipation(121 cycles,20.1% mean[SD] onset after 2.9[1.7]days, lasting for mean[SD] of 6.5[6 .1]) were the other common AEs. Grade3/4 AEs occurred in 6.7%(39/580) cycles. Compliance to dexamethasone and proton-pump inhibitors prescribed as part of mandatory SCMs was 98.2% and 98.3% respectively. Need based SCMs were required in 479 of the 580 cycles(82.6%) reporting AEs. Need-based SCMs were effective in relieving most symptoms (100% episodes of pain, cough and epigastric pain). Local physician consultation was sought in 18.1% and 15.8% episodes of vomiting and pain respectively. Proportion of patients with grade 3/4 AEs and requiring hospitalization was highest for mucositis(16.1% grade 3/4 and 9.7% hospitalized); followed by vomiting(10.1% grade3/4 and 8.7% hospitalized) and diarrhea(10.6% grade 3/4 and6.7% hospitalized). Hiccups, despite occurring in only 5 chemotherapy cycles(0.9%) did not improve with need based SCMs in 40%. Anemia was observed in 441(73.3% prevalence) chemotherapy cycles and was treated with blood transfusions, erythropoiesis-stimulating agents and intravenous iron supplementation in 47(10.7%), 30(6.8%) and four(0.9%) cycles respectively.
Conclusion:
This study highlights a high prevalence of AEs during LC chemotherapy. However, majority of episodes were grade 1-2 and were controlled with need-based SCMs, without requiring hospitalization or local physician consultation.
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P2.03 - Chemotherapy/Targeted Therapy (ID 704)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-053 - A Five-Year Audit of EGFR and ALK Testing at a Tertiary Care Centre in North India: More Sensitive Methods Do Make a Difference! (ID 10427)
09:30 - 09:30 | Author(s): Digambar Behera
- Abstract
Background:
Detection of targetable driver mutations in NSCLC may depend on the method employed. We carried out an audit to determine whether the EGFR mutation (EGFR-M) and ALK rearrangement (ALK-R) detection rate is dependent upon on the testing method used. We also sought to assess if EGFR-M and ALK-R was associated with baseline demographic characteristics.
Method:
Retrospective analysis of NSCLC patients who underwent testing for EGFR-M and ALK-R from January 2012 till May 2017. Methods used for EGFR-M were Real time ARMS PCR and gene sequencing while Break Apart FISH and D5F3 immunohistochemistry(IHC) were used for ALK-R testing.
Result:
Of the 599 patients tested for EGFR-M, 541 (90.3%) had interpretable results with an overall prevalence of 21.4%(n=116). Real time ARMS-PCR and gene sequencing yielded 95.9% and 81.9% interpretable results respectively. ALK-R testing was done in 462 patients of whom 431 (93.3%) had interpretable results, of which 8.6%(n=37) were positive. D5F3 IHC and Break Apart FISH yielded 94.7% and 82% interpretable results respectively. Mean age was 59.2 and 54.0 years respectively for EGFR-M and ALK-R patients with 54.3% and 45.1% being females. Mutations in exon 19 were the most common (n=81, 69.8%) followed by exon 21 L858R (n=30, 25.9%). 87/116 (75%) and 19/37 (51.4%) of EGFR-M and ALK-R patients received EGFR-TKIs and crizotinib respectively. Table shows differences in prevalence of EGFR-M and ALK-R prevalence in relation to gender, smoking status, histology and testing method used.Table 1 Smoking, gender and histologic profile of the patients tested for EGFR mutations and ALK rearrangements
EGFR-M positive (n=116) ALK-R positive (=37) Overall 21.4% 8.6% Adenocarcinoma only 23.8% 9.5% Females vs. males 37.1% vs. 14.3% 12.5% vs. 6.8% Non-smokers vs. smokers 34.6% vs. 11.9% 11.6% vs. 6.5% Female non smokers 39.9% 12.4% Male non-smokers 26.1% 10.5% Male smokers 11.1% 6.3% Females with adenocarcinoma 40.7% 13.3% Method used for testing 23.1% Real time ARMS PCR vs. 17.8% gene sequencing 9.0% D5F3 IHC vs. 4.9% Break Apart FISH
Conclusion:
Real time ARMS-PCR and D5F3 IHC are more sensitive methods for detecting EGFR-M and ALK-R respectively. Prevalence of a targetable driver in North Indian NSCLC patients ranges from 52.3% amongst female non-smokers to 17.4% of male smokers which are very encouraging results from both the patients and the treating oncologists perspectives. Higher percentage of EGFR-M patients receive targeted therapy as compared to ALK-R.
