Surgical outcomes from the phase 3 CheckMate 816 trial: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo alone as neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8503-8503
Author(s):  
Jonathan Spicer ◽  
Changli Wang ◽  
Fumihiro Tanaka ◽  
Gene Brian Saylors ◽  
Ke-Neng Chen ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Surgical Outcomes ◽  
Neoadjuvant Treatment ◽  
Phase 3 ◽  
Stage Ib ◽  
Viable Tumor ◽  
Duration Of Surgery ◽  
Definitive Surgery ◽  
Surgery Rates ◽  
Platinum Doublet

8503 Background: CheckMate 816 (NCT02998528) is a randomized phase 3 study of neoadjuvant NIVO + chemo vs chemo in resectable NSCLC. The study met its first primary endpoint, demonstrating significantly improved pathological complete response (pCR) with neoadjuvant NIVO + chemo. Here we report key surgical outcomes from the study. Methods: Adults with stage IB (≥ 4 cm)–IIIA (per AJCC 7th ed) resectable NSCLC, ECOG PS ≤ 1, and no known EGFR/ ALK alterations were randomized to NIVO 360 mg + platinum-doublet chemo Q3W or chemo Q3W for 3 cycles (n = 179 each). Definitive surgery was to be performed within 6 weeks of treatment. Primary endpoints are pCR (defined as 0% viable tumor cells in lung and lymph nodes) and event-free survival; both are evaluated by blinded independent review. Feasibility of surgery and surgery-related adverse events (AEs) are exploratory endpoints. Results: Baseline characteristics were comparable between arms; 64% of patients (pts) were stage IIIA. Definitive surgery rates were 83% with NIVO + chemo (n = 149) vs 75% with chemo (n = 135). Reasons for cancelled surgery were disease progression (12 and 17 pts, respectively), AEs (2 pts/arm), or other scenarios (14 and 19 pts, respectively; including pt refusal, unresectability, poor lung function). Minimally invasive surgery rates were 30% and 22%, and conversion from minimally invasive to open surgery rates were 11% and 16% for NIVO + chemo and chemo, respectively. Lobectomy was performed in 77% vs 61% of pts, and pneumonectomy in 17% and 25% for NIVO + chemo vs chemo, respectively. AEs were responsible for delays of surgery in 6 pts in the NIVO + chemo arm and 9 pts in the chemo arm. An R0 resection was achieved in 83% vs 78% of pts and median residual viable tumor (RVT) cells in the primary tumor bed were 10% vs 74% for NIVO + chemo vs chemo. There was no increase in median (Q1, Q3) duration of surgery and length of hospitalization between NIVO + chemo vs chemo (184 [130, 252] vs 217 [150, 283] min; and 10.0 [7, 14] vs 10.0 [7, 14] days, respectively). Any-grade and grade 3–4 surgery-related AEs were reported in 41% vs 47% and 11% vs 15% of the NIVO + chemo vs chemo arms, respectively. Grade 5 surgery-related AEs were reported in 2 vs 0 pts in the NIVO + chemo vs chemo arms; 0 vs 3 pts died due to treatment-related AEs, respectively. Conclusions: In CheckMate 816, neoadjuvant NIVO + chemo did not impede the feasibility and timing of surgery, nor the extent or completeness of resection vs chemo alone; treatment was tolerable and did not increase surgical complications. NIVO + chemo led to increased depth of pathological response. The surgical outcome data from CheckMate 816 along with significant improvement in pCR support NIVO + chemo as a potential neoadjuvant option for patients with stage IB to IIIA resectable NSCLC. Clinical trial information: NCT02998528.

Checkmate 816: A phase 3, randomized, open-label trial of nivolumab plus ipilimumab vs platinum-doublet chemotherapy as neoadjuvant treatment for early-stage NSCLC.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS8577-TPS8577 ◽  
Author(s):  
Patrick M. Forde ◽  
Jamie E. Chaft ◽  
Enriqueta Felip ◽  
Stephen Broderick ◽  
Nicolas Girard ◽  
...  
Keyword(s):  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitor ◽  
Checkpoint Inhibitors ◽  
Early Stage ◽  
Neoadjuvant Treatment ◽  
Stage Ib ◽  
Early Stage Nsclc ◽  
Iiia Nsclc ◽  
Doublet Chemotherapy ◽  
Platinum Doublet

TPS8577 Background: At initial diagnosis, 20% of patients (pts) with NSCLC present with early-stage disease. The 5-year overall survival (OS) rate after surgery for stage IB–IIIA NSCLC is 25%–60%. Addition of adjuvant chemotherapy to surgery only provides a 5% absolute OS benefit at 5 years. Neoadjuvant treatment with immune checkpoint inhibitors may extend OS in early-stage NSCLC by enhancing systemic immunity and eradicating micrometastatic disease. In contrast to the adjuvant setting, the neoadjuvant setting is associated with a higher tumor burden, the presence of abundant tumor antigens, and the consequent potential for tumor-associated neoantigen presentation to the immune system. In an ongoing feasibility trial in pts with stage IB–IIIA NSCLC, nivolumab (nivo; a fully human PD-1 immune checkpoint inhibitor antibody) given alone as neoadjuvant treatment induced a major pathological response (MPR; < 10% residual viable tumor cells) rate of 39% (7/18), did not delay or interfere with surgery, and was not associated with new safety signals. In a phase 1 study in pts with stage IIIB/IV NSCLC, first-line nivo + ipilimumab (ipi; a CTLA-4 immune checkpoint inhibitor antibody) showed a greater radiologic objective response rate than nivo alone (39% vs 23%). These data provided the rationale for Checkmate 816 (NCT02998528), a phase 3 study evaluating nivo + ipi vs platinum-doublet chemotherapy as neoadjuvant treatment for early-stage NSCLC. Methods: Approximately 326 pts aged ≥18 years with resectable stage IB/II/IIIA NSCLC, ECOG performance status 0–1, pulmonary function capable of tolerating lung resection, and available lung tumor tissue will be enrolled in North America, South America, Europe, and Asia. Pts are ineligible if they have autoimmune disease or had received prior treatment with immune checkpoint inhibitors. Pts will be randomized to receive nivo + ipi or platinum-doublet chemotherapy. The primary endpoint is MPR rate. Secondary endpoints include event-free survival, OS, and complete pathological response. Start date is January 2017. The estimated primary completion date is July 2019. Clinical trial information: NCT02998528.

scholarly journals Microsurgical unilateral laminotomy for bilateral decompression of degenerative lumbar canal stenosis: a comparative study

2019 ◽  
Vol 55 (1) ◽  
Author(s):  
Mohamed I. Refaat ◽  
Amr K. Elsamman ◽  
Adham Rabea ◽  
Mohamed I. A. Hewaidy
Keyword(s):  
Patient Satisfaction ◽  
Blood Loss ◽  
Minimally Invasive ◽  
Invasive Technique ◽  
Decompression Surgery ◽  
Microsurgical Decompression ◽  
Significant Difference ◽  
Duration Of Surgery ◽  
Group A ◽  
Group B

Abstract Background The quest for better patient outcomes is driving to the development of minimally invasive spine surgical techniques. There are several evidences on the use of microsurgical decompression surgery for degenerative lumbar spine stenosis; however, few of these studies compared their outcomes with the traditional laminectomy technique. Objectives The aim of our study was to compare outcomes following microsurgical decompression via unilateral laminotomy for bilateral decompression (ULBD) of the spinal canal to the standard open laminectomy for cases with lumbar spinal stenosis. Subjects and methods Cases were divided in two groups. Group (A) cases were operated by conventional full laminectomy; Group (B) cases were operated by (ULBD) technique. Results from both groups were compared regarding duration of surgery, blood loss, perioperative complication, and postoperative outcome and patient satisfaction. Results There was no statistically significant difference between both groups regarding the improvement of visual pain analogue, while improvement of neurogenic claudication outcome score was significant in group (B) than group (A). Seventy-three percent of group (A) cases and 80% of group (B) stated that surgery met their expectations and were satisfied from the outcome. Conclusion Comparing ULBD with traditional laminectomy showed the efficacy of the minimally invasive technique in obtaining good surgical outcome and patient satisfaction. There was no statistically significant difference between both groups regarding the occurrence of complications The ULBD technique was found to respect the posterior spinal integrity and musculature, accompanied with less blood loss, shorter hospital stays, and shorter recovery periods than the open laminectomy technique.

eMonarcHER: A phase 3 study of abemaciclib plus standard adjuvant endocrine therapy in patients with HR+, HER2+, node-positive, high-risk early breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS596-TPS596
Author(s):  
Sara M. Tolaney ◽  
Lesley Fallowfield ◽  
Peter A. Kaufman ◽  
Eva M. Ciruelos ◽  
Mary Corona Gainford ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Endocrine Therapy ◽  
Early Breast Cancer ◽  
Primary Breast Tumor ◽  
Phase 3 ◽  
Free Survival ◽  
Node Positive ◽  
High Risk Disease ◽  
Definitive Surgery

TPS596 Background: Hormone receptor positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with high-risk characteristics has a high risk of disease recurrence. Novel therapeutic options for this population are urgently needed. Abemaciclib is an oral, selective, and potent CDK4 & 6 inhibitor administered on a continuous schedule which is approved for HR+, HER2- advanced BC (ABC) as monotherapy and in combination with endocrine therapy (ET). Abemaciclib combined with ET demonstrated a statistically significant improvement in invasive disease-free survival (IDFS) in participants (pt) with HR+, HER2-, node-positive, high risk early breast cancer (EBC) and also clinical activity in HR+, HER2+ ABC. The eMonarcHER trial investigates whether abemaciclib plus ET will improve IDFS in pts with HR+, HER2+, node-positive, high risk EBC. Methods: eMonarcHER is a phase 3 global, randomized, double-blinded, placebo (PB)-controlled trial in participants with HR+, HER2+, node-positive, high risk EBC who have completed adjuvant HER2-targeted therapy (tx). Eligible participants are randomized 1:1 to receive either abemaciclib 150 mg twice daily or PB, plus standard ET. Study intervention period will be ≤26 cycles (approximately 2 years) followed by ≤8 years of ET as medically indicated. Participants must have undergone definitive surgery of the primary breast tumor and have high-risk disease. High-risk disease is defined as (i) detection of residual axillary nodal disease at the time of definitive surgery in participants with prior neoadjuvant (neoadj) tx; or (ii) in patients not receiving neoadj tx, must have either ≥4 pathologically positive axillary lymph nodes (pALNs), or 1-3 pathological pALNs and either: histologic Grade 2-3 and/or primary invasive tumor size ≥5 cm. Participants must have received either adjuvant pertuzumab plus trastuzumab with chemotherapy or adjuvant T-DM1. Stratification factors include treatment with neoadj tx, menopausal status, and region. The study is powered at approximately 80% to detect the superiority of abemaciclib plus ET over PB plus ET in terms of IDFS (as defined by the STEEP system) at a 1-sided α =.025 using a log-rank test. Assuming a hazard ratio of 0.73, this requires approximately 324 events at final IDFS analysis. Key secondary objectives include overall survival, distant relapse free survival, safety, pharmacokinetics, and patient-reported outcomes. The study is planned to start in March 2021. Approximately 525 centers in 23 countries plan to enroll ̃2450 participants. Clinical trial information: NCT04752332.

Tissue Engineered Successful Reconstruction of a Complex Traumatized Lower Extremity

2021 ◽  
Vol 11 (9) ◽  
Author(s):  
Srinjoy Saha
Keyword(s):  
Minimally Invasive ◽  
Soft Tissues ◽  
Platelet Rich Plasma ◽  
Thigh Muscle ◽  
Muscle Injuries ◽  
Invasive Approach ◽  
Novel Approach ◽  
Duration Of Surgery ◽  
Biomaterial Application ◽  
Split Skin

Introduction: Tissue engineered reconstruction is a minimally invasive approach for healing major complex wounds successfully. It combines accurate, conservative debridement with a specially adapted suction method, platelet-rich plasma (PRP) injections, and biomaterial application to salvage injured tissues and grows new soft tissues over wounds. Case Report: A healthy young man in his early 30s presented to our emergency department with complex knee-thigh injuries following a high-velocity automobile accident. Degloved anterolateral thigh, severe thigh muscle injuries, and ruptured extensor patellar mechanism were observed. Accurate conservative (as opposed to radical) debridement and PRP injections salvaged the injured muscles and tendons. Specially carved reticulated foam wrapped around the injured ischemic muscles, followed by low negative, short intermittent, cyclical suction therapy. Wound exploration 4 days apart revealed progressive improvements with considerable vascularization of the injured soft tissues within 2 weeks. Thereafter, meticulous reconstruction of the salvaged muscles and tendons restored anatomical congruity. An absorbable synthetic biomaterial covered the sizeable open wound with vast areas of exposed tendons. Five weeks later, exuberant granulating tissue ingrowth within the biomaterial filled up the tissue defect. A split-skin graft covered the remaining raw areas, which “took” completely. Early rehabilitation enabled the patient to return to active work, play contact sports, and perform strenuous activities effortlessly. Conclusion: Minimally invasive tissue engineered reconstruction is a novel approach using a series of simple minimally invasive procedures. It lessens the duration of surgery and anesthesia, maximizes soft-tissue salvage, lowers morbidity, minimizes hospitalization, saves costs, and improves the patient’s quality of life significantly. Keywords: Mangled extremity, Limb salvage, Financial, Trauma, Modified negative pres

scholarly journals Early experience with laparoscopic extralevator abdominoperineal excision within an enhanced recovery setting: analysis of short-term outcomes and quality of life

2011 ◽  
Vol 93 (6) ◽  
pp. 451-459 ◽  
Author(s):  
PG Vaughan-Shaw ◽  
AT King ◽  
T Cheung ◽  
NE Beck ◽  
JS Knight ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Median Duration ◽  
Enhanced Recovery ◽  
Neoadjuvant Treatment ◽  
Abdominoperineal Excision ◽  
Short Term ◽  
Invasive Approach ◽  
Enhanced Recovery Programme ◽  
Duration Of Surgery

INTRODUCTION Conventional abdominoperineal excision for low rectal cancer has a higher local recurrence and reduced survival compared to anterior resection. An extralevator abdominoperineal excision (ELAPE) may improve outcome through removal of increased tissue in the distal rectum. Experience with ELAPE is limited and no studies have reported on quality of life (QOL) following this procedure. We describe a minimally invasive approach to ELAPE within an enhanced recovery programme, and present short-term results and QOL analyses. METHODS All laparoscopic ELAPEs were included in a prospective database. Demographics, intra-operative and post-operative outcomes were evaluated. Postoperative QOL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29. RESULTS Thirteen laparoscopic ELAPEs were performed over a two-year period. All were enrolled in an enhanced recovery programme. The median age was 76. The median tumour height was 20mm (range: 0–50mm) from the dentate line and all patients received neoadjuvant treatment. The median duration of surgery was 300 minutes (range: 120–488 minutes), the mean blood loss was 150ml and one procedure was converted to open surgery. There was no circumferential resection margin involvement or tumour perforation. The median duration of use of intravenous fluid, patient controlled analgesia and urinary catheterisation was 2, 2 and 2.5 days respectively and the median length of hospital stay was 7.5 days. Two patients developed perineal wound dehiscence. QOL analysis revealed high global health status (90.8), physical (91.3), emotional (98.3) and social functioning (100) scores, which compared favourably with EORTC reference values and published QOL scores following conventional abdominoperineal excision. CONCLUSIONS Laparoscopic ELAPE within an enhanced recovery setting is a feasible and safe approach with acceptable short-term outcomes and post-operative quality of life.

scholarly journals Surgical Outcomes of Phacoemulsification Surgery in a Restructured Asian Training Hospital

1970 ◽  
Vol 12 (4) ◽  
pp. 201-207
Author(s):  
David Zhiwei Law ◽  
Seng Chee Loon ◽  
Wan Ling Wong ◽  
Marilou Sevilla Ebreo ◽  
Xiang Li ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Surgical Outcomes ◽  
Perioperative Complications ◽  
University Hospital ◽  
Complication Rates ◽  
Corrected Visual Acuity ◽  
Duration Of Surgery ◽  
National University ◽  
Chi Squared ◽  
Best Corrected Visual Acuity

Aim: To evaluate the surgical outcomes of phacoemulsification performed at National University Hospital, Singapore, with emphasis on the results achieved by residents.Methods: This was a retrospective analysis of surgical outcomes of patients who underwent phacoemulsification in a restructured hospital in 2008. The study included 318 eyes of patients of predominantly Asian descent. Pre- and postoperative best-corrected visual acuity, perioperative complications and associations of patient, surgical and surgeon factors were studied. One-way analysis of variance for means, chi-squared test for proportions, and multivariate analyses were performed to determine factors associated with postoperative best-corrected visual acuity outcomes. Main outcome measures included postoperative best-corrected visual acuity, degree of improvement in best-corrected visual acuity, and achievement of specific best-corrected visual acuity targets of 6/9 and 6/12 at postoperative months 1 and 3.Results: Duration of surgery of less than 20 minutes was found to be significantly associated with better postoperative best-corrected visual acuity. Level of surgical experience was also associated with betterpostoperative best-corrected visual acuity at postoperative months 1 (p < 0.001) and 3 (p = 0.004). While senior consultants produced the best postoperative best-corrected visual acuity outcomes, the results achieved by residents were comparable to those reported in prior resident-only studies. For surgeries performed by residents, the overall rate of posterior capsule rupture was 3.1% with a 0.0% rate of vitreous loss.Conclusions: The continued close guidance and training of ophthalmology residents in a restructured Asian training hospital will ensure that complication rates remain low while maintaining postoperative outcomes at safe levels.

scholarly journals Discrepency in grade between preoperative biopsy and final specimen in stage I carcinoma endometrium: an institutional review

2019 ◽  
Vol 7 (2) ◽  
pp. 568
Author(s):  
Suhaildeen Kajamohideen ◽  
Balasubramanian Venkitaraman ◽  
Sridevi V.
Keyword(s):  
Histological Grade ◽  
Tumour Size ◽  
Demographic Data ◽  
Median Number ◽  
Laparoscopic Staging ◽  
Surgical Biopsy ◽  
Carcinoma Endometrium ◽  
Duration Of Surgery ◽  
Diagnostic Biopsy ◽  
Definitive Surgery

Background: Most endometrioid endometrial cancer are well differentiated (Grade I). Grade of the tumor is an important predictor of nodal metastasis and the discordance in histological grade of endometrial cancers between diagnostic biopsy and definitive surgery specimen was analyzed in our Institute.Methods: Around 221 patients diagnosed with carcinoma endometrium between 2006 and 2014 were taken into study. Histologic differentiation of the tumour between diagnostic biopsy and definitive surgery were analysed. All demographic data, tumor factors, follow up and recurrence were recorded.Results: Of the 221 patients taken into consideration for analysis, median age of presentation was 57 years with range between 38-77 years. The overall median body mass index was 27.70kg/m2. 66 % of patients had comorbid illness, with 33% having both diabetes and hypertension. Open staging was performed in 150 patients and laparoscopic staging in 71 patients. Mean duration of surgery was 3.06 hrs in laparoscopic staging and 2.74hrs in open staging. The median tumour size was 4cm.The median number of nodes dissected were 13. Discordance in the grade of tumour between diagnostic biopsy and surgical biopsy were 58.8% of grade 1 tumour, 16.2% of grade 2 tumours and 18.9% of grade 3 tumours.Conclusions: Discrepancies in correlation of the grade of tumour in diagnostic biopsy and tissue obtained at surgery supports the need for surgical staging in all patients.

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