June 27, 2022

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2022 ASCO: 4 Highlights about Non-Metastatic Non-Small Cell Lung Cancer

2022 ASCO: 4 Highlights about Non-Metastatic Non-Small Cell Lung Cancer



 

2022 ASCO: 4 Highlights about Non-Metastatic Non-Small Cell Lung Cancer.

The 58th American Society of Clinical Oncology (ASCO) Annual Meeting will be held from June 3 to 7, 2022  in the United States.

As the premier communication event in the oncology community, the ASCO Annual Meeting brings the most cutting-edge tumor research content every year.

ASCO’s official website has officially released the abstract collection of this meeting.  We has compiled oral reports on non-metastatic non-small cell lung cancer (NSCLC) for readers.

There are four hightlights about Non-Metastatic Non-Small Cell Lung Cancer as belows:

 

2022 ASCO: 4 Highlights about Non-Metastatic Non-Small Cell Lung Cancer!

2022 ASCO: 4 Highlights about Non-Metastatic Non-Small Cell Lung Cancer!

 


1. ASCO Voice of China丨neoSCORE study shows that three-cycle sintilimab + platinum-containing double-drug chemotherapy has a higher MPR rate than two-cycle MPR

 This study explored the efficacy of neoadjuvant chemotherapy in combination with immunotherapy in non-small cell lung cancer.

According to preliminary summary data, the major pathological response (MPR) rate of 3 cycles of neoadjuvant therapy was numerically higher than that of 2 cycles, and the response was excellent in patients with squamous cell carcinoma.

 

Title: Randomized, single-center, two-arm phase II neoSCORE study: sintilimab + platinum-based doublet chemotherapy (two cycles vs three cycles) neoadjuvant therapy for resectable NSCLC (oral presentation session 8500)

Two cycles versus three cycles of neoadjuvant sintilimab plus platinum-doublet chemotherapy in patients with resectable non-small-cell lung cancer (neoSCORE): A randomized, single center, two-arm phase II trial.

 

Background:

Neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy has promising efficacy in resectable non-small cell lung cancer (NSCLC), but the role in neoadjuvant immunochemotherapy has not been established. This phase II study compared the efficacy and safety of 2 cycles with 3 cycles of neoadjuvant sintilimab plus chemotherapy in resectable stage IB-IIIA NSCLC.

 

Method:

This randomized, open-label phase II trial enrolled patients 18 years of age or older with histologically-proven, treatment-naïve, American Joint Committee on Cancer-defined stage IB-IIIA, resectable NSCLC.

Eligible patients were randomly assigned on day 1 of a 3-week cycle to receive 2 or 3 cycles of intravenous sintilimab (200 mg) in combination with carboplatin (AUC5) and nab-paclitaxel (260 mg/m2, squamous). cell carcinoma) or pemetrexed (500mg/m2, non-squamous cell carcinoma) neoadjuvant therapy.

After surgical resection, the patient received a total of 4 sessions of perioperative immunochemotherapy, followed by 1-year maintenance therapy with sintilimab at the patient’s discretion. Randomization was stratified by tumor PD-L1 expression (≥1% vs <1%). The primary endpoint was the major pathological response (MPR) rate.

Secondary endpoints included pathological complete response (pCR) rate, objective response rate (ORR), 2-year disease-free survival (DFS) rate, 2-year overall survival (OS) rate, and safety (NCT04459611).

 

Results:

From June 2020 to September 2021, 60 patients were enrolled and received neoadjuvant therapy. The patient characteristics of the two groups were well balanced.

Among 55 patients with successful R0 resection, it was observed that the MPR rate in the three-cycle group (41.4%, 12/29) was higher than that in the two-cycle group (26.9%, 7/26) (P=0.260).

Meanwhile, the pCR rates were respectively Reached 24.1% (7/29) and 19.2% (5/26) (P=0.660).

Patients with the squamous subtype generally had a statistically higher MPR rate (51.6%, 16/31) than those with the non-squamous subtype (12.5%, 3/24) (P=0.002).

In the squamous subgroup, the MPR rate induced by 3 cycles of neoadjuvant therapy was 60%, compared with 43.8% after 2 cycles (P=0.366).

Meanwhile, the MPR rates in the non-squamous subgroup were 21.4% and 0%, respectively (P=0.239). There was no significant difference in ORR between the 3-cycle group (55.2%, 16/29) and the 2-cycle group (50%, 13/26) (P=0.701).

Both groups were well tolerated, and 5% (3/60) had grade 3 immune-related adverse events.

 

In conclusion

This is the first randomized study comparing different periods of immunochemotherapy in the context of neoadjuvant therapy.

The MPR rate of 3 cycles of neoadjuvant therapy was numerically higher than that of 2 cycles.

Compared with the non-squamous subtype, patients with squamous lung cancer achieved better MPR rates.

 

 


2. NADIM study: Immune combined chemotherapy significantly improves the PR rate of stage IIIA NSCLC, with SOC potential

Professor Mariano Provencio-Pulla from Instituto Investigacion Sanitaria Puerta de Hierro-Segovia de Arana will present the results of the NADIM study orally at the formal meeting.

This study confirms the efficacy of neoadjuvant immunotherapy combined with chemotherapy in resectable NSCLC and is expected to become the standard of care (SOC).

 

Title: Pathological Complete Response (pCR) in Phase II NADIM Study Primary Endpoint: Nivolumab + Chemotherapy vs Chemotherapy Neoadjuvant Therapy for Resectable Stage IIIA NSCLC (Oral Presentation Session 8501)

Nivolumab + chemotherapy versus chemotherapy as neoadjuvant treatment for resectable stage IIIA NSCLC: Primary endpoint results of pathological complete response (pCR) from phase II NADIM II trial.

 

Background

Non-small cell lung cancer (NSCLC) is incurable in most patients with locally advanced stage IIIA disease.

Previous findings suggest that the use of neoadjuvant chemoimmunotherapy, which increases the percentage of cured patients, is a promising treatment option, but must be tested in randomized clinical trials.

 

Method

NADIMII (NCT03838159) is an open-label, randomized, two-group, phase II, multicenter clinical trial.

Patients with resectable clinical stage IIIA NSCLC, ECOGPS0-1 and no known EGFR/ALK mutation were randomly assigned to receive nivolumab (NIVO) 360mg + paclitaxel 200mg/m2 + carboplatin AUC 5 Q3W every 21 days (+ /-3 days) as neoadjuvant therapy followed by surgery, or paclitaxel 200mg/m2 + carboplatin AUC 5, 1 cycle every 21 days (+/- 3 days) for 3 cycles followed by surgery.

In patients with R0 resection confirmed by pathological evaluation, adjuvant NIVO administration was started within 3-8 weeks (+7 days) after surgery and continued for 6 months.

The primary endpoint was pathological complete response (pCR) assessed by blinded independent pathology review (BIPR) in the intent-to-treat population (ITT).

pCR was defined as 0% viable tumor cells in the resected lung and lymph nodes; patients who did not undergo surgery were classified as non-responders.

Secondary endpoints included major pathological response (MPR) assessed by BIPR; ≤10% of viable tumors), overall response rate (ORR), toxicity profile and potential predictive biomarkers.

 

Results:

Between February 8, 2019, and November 11, 2021, 90 patients were enrolled, of which 87 were effective.

In ITT, neoadjuvant NIVO+chemotherapy significantly increased the pCR rate compared with chemotherapy (36.2% vs 6.8%; relative risk (RR) 5.25 (P=0.0071).

In ITT, NIVO+chemotherapy also improved compared with chemotherapy MPR rates (52% vs 14%) and ORR (74% vs 48%).

91% of patients who received NIVO + chemotherapy and 69% of patients who received chemotherapy underwent radical surgery; 1 and 4 in the experimental and control groups, respectively It is rare for patients to cancel surgery due to AEs (1 patient/trial group) and disease progression.

The proportion of patients reporting grade 3-4 related AEs in the NIVO+ chemotherapy group and chemotherapy group was 24% and 10%, respectively.

In the ITT trial In the group, PD-L1TPS in pCR patients (median 70%, IQR 5%-90%) was higher than that in non-responders (median 0%, IQR 0%-37.5%, P=0.0035).

AUC was 0.734 (P=0.005). The pCR rate increased with increasing PD-L1 TPS class (<1% for 14.3%; 1%-49% for 41.7%; ≥50% for 61.1%; P=0.008 ).

 

In conclusion

This study demonstrates the superiority of chemoimmunotherapy in pCR in patients with resectable stage IIIA NSCLC, as well as the feasibility of surgery, with a moderate increase in grade 3-4 toxicity.

Therefore, this treatment should become the standard of care for these patients. (Clinical trial information: NCT03838159)

 

 


3. Intraoperative quality index monitoring significantly improves the disease-free survival rate after lung cancer resection

Prof. Brendan Heiden, Washington University School of Medicine, St. Louis, MO, will give an oral presentation at the formal meeting on the role of a new surgical quality score in the assessment of overall patient survival, which will help analyze related outcomes factors to improve the quality of life of patients.

 

Title: Relationship between Intraoperative Quality Index and Postoperative Survival Rate in Lung Cancer Resection (Oral Report Session 8502)

Intraoperative quality metrics and association with survival following lung cancer resection.

 

Background

We conducted a retrospective cohort study using a uniquely compiled dataset of US veterans with clinical stage I NSCLC undergoing definitive surgical treatment.

Based on contemporary treatment guidelines, 5 surgical QMs were defined: prompt surgery (within 12 weeks of diagnosis), minimally invasive approach, anatomic resection by lobectomy, adequate lymph node sampling (≥10 lymph nodes), and negative margins. Using a multivariate Cox proportional hazards model, a surgical quality score was developed to reflect the relationship between these QMs and overall survival (OS), and the relationship between this score and disease-free survival (DFS) was also examined.

 

Method

The study included 9,628 veterans who underwent surgery between 2006 and 2016. The following QMs were met: prompt surgery (n=6,633, 68.9%), minimally invasive approach (n=3,986, 41.4%), lobectomy (n=6,843, 71.1%), adequate lymph node sampling (n=3,278, 34.1%) ) and negative surgical margins (n=9,312, 96.7%).

Median (IQR) follow-up was 6.2 (2.5-11.4) years. Standardized scores were constructed from 0 (not meeting QMs) to 100 (meeting all QMs), with higher scores indicating progressive improvement in risk-adjusted OS (Table).

The median (IQR) OS for the highest scoring quintile was 86.8 (37.8-149.6) months, and the median (IQR) OS for the lowest scoring quintile was 25.3 (7.1-45.8) months.

Recurrence was detected in 2,268 (23.6%) patients. Higher surgical quality scores were associated with improved DFS (multivariate adjusted hazard ratio, aHR=0.494, 95%CI 0.245-0.997).

 

Results:

The study included 9,628 veterans who underwent surgery between 2006 and 2016. The following QMs were met: prompt surgery (n=6,633, 68.9%), minimally invasive approach (n=3,986, 41.4%), lobectomy (n=6,843, 71.1%), adequate lymph node sampling (n=3,278, 34.1%) ) and negative surgical margins (n=9,312, 96.7%). Median (IQR) follow-up was 6.2 (2.5-11.4) years.

Standardized scores were constructed from 0 (not meeting QMs) to 100 (meeting all QMs), with higher scores indicating progressive improvement in risk-adjusted OS (Table).

The median (IQR) OS for the highest scoring quintile was 86.8 (37.8-149.6) months, and the median (IQR) OS for the lowest scoring quintile was 25.3 (7.1-45.8) months.

Recurrence was detected in 2,268 (23.6%) patients. Higher surgical quality scores were associated with improved DFS (multivariate adjusted hazard ratio, aHR 0.494, 95% CI 0.245-0.997).

 

In conclusion

Adherence to intraoperative QMs was associated with significant improvements in overall and disease-free survival.

Efforts to improve adherence to surgical QMs can significantly improve patient outcomes after curative resection of early-stage lung cancer.

 

 


4. Neoadjuvant therapy combined with radiotherapy did not improve the survival of patients with stage III-N2 NSCLC

Prof. Marah Akhdar from Department of General Surgery and Urology, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan will give an oral presentation at the official conference on the effect of adding radiotherapy to induction therapy for stage III-N2 NSCLC on patient survival Impact.

The results showed that the addition of radiotherapy did not improve survival in this subset of patients.

 

Title: A Population-Based Study: Neoadjuvant Chemoradiation vs Neoadjuvant Chemotherapy for Stage III-N2M0 NSCLC (Oral Presentation Session 8503)

Neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy for patients with stage III-N2M0 non-small cell lung cancer (NSCLC): A population-based study.

 

Background

Stage III-N2 non-small cell lung cancer (NSCLC) is a heterogeneous disease with controversial treatment options.

Induction therapy as part of multimodal therapy is the standard of care for stage III-N2 NSCLC. The aim of this study was to investigate the effect of neoadjuvant chemotherapy plus radiotherapy on survival outcomes.

 

Method

All adult patients with NSCLC diagnosed between 2004-2015 were identified in the Surveillance, Epidemiology, and End Results (SEER) database using the ICD-O-3 histologic type code.

Inclusion criteria: patients with stage III NSCLC, ipsilateral lymph node involvement (N2), any T stage, and no known distant metastasis (M0).

The main sub-cohort of the study was patients who received chemoradiotherapy (CRT) or chemotherapy (CT) in the neoadjuvant setting.

The primary outcomes were overall survival (OS) and cancer-specific survival (CSS).

Cox proportional hazards models were used to analyze the effects of each treatment on OS and CSS in univariate and multivariate ways.

Multivariate analysis adjusted for age, sex, marital status, T stage, lymph node dissection status, tumor histology, primary site, laterality, and surgical procedure.

Apply inverse probability processing weighting (IPTW) to create a weighted sample based on study covariates.

 

Results:

The analysis included 1175 patients; 799 (68.0%) received neoadjuvant CRT and 376 (32.0%) received neoadjuvant CT.

The median age of the sample was 63 years (IQR: 56-69).

Stage T2 was the most common (N=561, 47.7%), followed by T4 (N=243, 20.7%), T1 (N=228, 19.4%) and T3 (N=143, 12.2%).

The primary tumor histology in 773 (65.8%) patients was non-squamous cell carcinoma.

The upper lobe was the most common primary tumor site (N=788, 67.1%). Patients underwent lobectomy (N=917, 78.0%), pneumonectomy (N=184, 15.7%), or sublobar resection (N=69, 5.9%).

In the neoadjuvant setting, the addition of RT to chemotherapy showed a slightly higher median OS than chemotherapy alone (51 vs. 47 months, respectively) and a higher median CSS (75 vs. 59 months, respectively) months).

However, these differences in OS or CSS were not statistically significant (HR=1.08, 95%CI: 0.91-1.28 and HR=1.04, 95%CI: 0.89-1.21, respectively).

After adjustment, age, T3-T4 stage, non-squamous histology, lower lobe primary site, positive resected lymph nodes, and pneumonectomy were all significant independent predictors of worse OS and CSS.

IPTW analysis showed no significant survival advantage in OS and CSS in CRT patients (HR=1.15, 95%CI: 0.95-1.40 and HR=1.12, 95%CI: 0.90-1.39).

 

In conclusion

The addition of radiotherapy to neoadjuvant CT did not produce a significant survival benefit.

Multiple prognostic factors should be considered in determining the optimal choice and sequence of multimodal therapy for patients with stage III-N2M0 NSCLC.

 

 

 

2022 ASCO: 4 Highlights about Non-Metastatic Non-Small Cell Lung Cancer!

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