NEPA as antiemetic prophylaxis after failure of 5HT3-RA plus dexamethasone in patients receiving carboplatin and gemcitabine chemotherapy: A monocentric real-life experience

2020 ◽  
pp. 107815522092940
Author(s):  
Maria Rosaria Valerio ◽  
Vittorio Gebbia ◽  
Nicolò Borsellino ◽  
Maria La Vecchia ◽  
Vincenzo Serretta ◽  
...  
Keyword(s):  
Combination Chemotherapy ◽  
Rescue Medication ◽  
Life Experience ◽  
Real Life ◽  
Complete Response ◽  
Antiemetic Prophylaxis ◽  
Phase 0 ◽  
Subsequent Cycle ◽  
Delayed Cinv

Introduction Chemotherapy-induced nausea and vomiting (CINV) may affect adherence to planned chemotherapy treatments and compromise patients’ quality of life during the therapy. NEPA is an oral fixed combination of netupitant, a highly-selective NK1-RA and palonosetron, a 5HT3-RA, approved for the prevention of acute and delayed CINV. The aim of this study was to evaluate the efficacy and safety of NEPA with dexamethasone for CINV prophylaxis in the challenging setting of carboplatin and gemcitabine combination chemotherapy, after failure of prophylaxis with 5HT3 receptor antagonist. Methods Eligible patients were undergoing carboplatin and gemcitabine combination chemotherapy for metastatic non-small cell lung cancer (NSCLC), ovarian cancer or urothelial cancer and experienced nausea and/or vomiting after the first cycle of chemotherapy, despite an antiemetic prophylaxis with a 5HT3-RA and dexamethasone. Primary efficacy endpoint was complete response (CR: no emesis, no rescue medication) obtained with NEPA, during the overall phase (0–120 h), after the start of chemotherapy. Results During the first cycle of chemotherapy, 15 out of 30 (50%) patients did not properly control CINV with a 5HT3-RA plus dexamethasone used as primary antiemetic prophylaxis and then were switched to NEPA from the subsequent cycle. During NEPA administration, 13 out of 15 patients (86.7%) achieved an overall CR (no emesis, no rescue medication). Antiemetic treatment with NEPA was very well tolerated with only two patients (13.3%) that experienced a grade 1 TEAE. Conclusions Our experience showed that NEPA has proven to be very effective and well tolerated in the prophylaxis of CINV induced by carboplatin-based chemotherapy.

scholarly journals Analysis of Quality-of-Life (QoL) in Patients Receiving NEPA for Prevention of Chemotherapy-Induced Nausea (CINV) and Vomiting

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 44-45
Author(s):  
Meinolf Karthaus ◽  
M O Zahn ◽  
B Tschechne ◽  
B. Gerber ◽  
S Haas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rescue Medication ◽  
Daily Life ◽  
Real Life ◽  
Final Analysis ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Antiemetic Guidelines ◽  
Delayed Phase

Introduction: Chemotherapy-induced nausea and vomiting (CINV) is a common and distressing side effect that has a detrimental impact on QoL. For pts receiving highly emetogenic chemotherapy (HEC), which includes those on anthracycline-cyclophosphamide (AC)-based regimens, a triple combination of a neurokinin-1 receptor antagonist (NK1 RA), a 5-hydroxytryptamine-3 (5-HT3) RA and dexamethasone is recommended by the NCCN and MASCC/ESMO. The complexity of the NK1 RA-based schedules may be a reason for the low adherence to antiemetic guidelines and a not sufficient control of CINV in pts receiving HEC and MEC. NEPA is the only available fixed-combination antiemetic. It is composed of an NK1 RA, netupitant (300 mg) and a 5-HT3 RA, palonosetron (0.50 mg); thus, it acts by blocking two main emetic pathways in a single dose and eases compliance to guidelines. Methods: Prospective, non-interventional study at 162 sites in Germany from 09/2015 to 03/2018. The aim was to determine QoL of adult cancer pts receiving NEPA for the prevention of nausea and vomiting associated with 1 or 2 day HEC or MEC in daily clinical practice. The primary outcome was measured via the Functional Living Index-Emesis (FLIE) questionnaire. FLIE questionnaires were analyzed according to the FLIE scoring and administration manual v12; higher scores correlated to better performance on daily life activities due to the lower occurrence of nausea and vomiting. 'No impact on daily life (NIDL) activities' for individual nausea and vomiting domains was defined as a FLIE score higher than 53.8; NIDL for the combined domains of nausea and vomiting was defined as a FLIE score higher than 108. Secondary objectives included evaluating effectiveness, as determined by measuring the rate of complete response (CR) and rescue medication, as well as safety outcomes. Efficacy was documented by the treating physicians and via patient diaries for 3 Ctx cycles within 24 hrs and on 4 additional d after Ctx. Safety, additional medication and physicians' overall satisfaction was reported via eCRF. Results: A total of 2429 pts were enrolled, 2405 of whom were assessed for eligibility; of these, 2173 were included in the final analysis and constitute the full analysis set population (FAS). Evaluable FLIE questionnaires were collected from 1886 (88%) pts in cycle 1, 1795 (88%) pts in cycle 2 and 1698 (86%) pts in cycle 3. A total of 1389 pts received HEC and 764 MEC in cycle 1. The majority of pts (91%) were scheduled to receive 1-day ctx at study entry. More than half of the pts (1230, 56%) received anthracycline/cyclophosphamide-(AC), 19% carboplatin-, 8% cisplatin-, 7% oxaliplatin- and 9% other CTs. NIDL due to vomiting during cycle 1 was reported by 84% of pts in the HEC group and 82% in the MEC group. These frequencies were maintained in cycles 2 and 3. NIDL due to nausea increased from 54% in cycle 1 to 58% in cycle 3 for pts receiving HEC, and from 59% in cycle 1 to 66% in cycle 3 for pts in the MEC group. The rates for the combined domain of NIDL due to nausea and vomiting were consistent across cycle 1 (64%) and in cycles 2 and 3 (66% in each cycle) for pts in the HEC group, while the rates increased from 67% in cycle 1 to 73 and 74% in cycles 2 and 3, respectively, for pts receiving MEC. The CR rate (no emesis and no use of rescue medication) was 89% in the acute phase (0-24 h), 87% in the delayed phase (25-120 h) and 83% in the overall period (0-120 h) in cycle 1. The no significant nausea (NSN) rate was 79 % in the acute, 75 % in the delayed and 67 % in the overall phase in cycle. The majority of physicians (≥89%) and pts (≥86%) rated the effectiveness of NEPA prophylaxis as 'very good' or 'good' during all three ctx cycles. The most common NEPA-related AEs, which occurred in >1% of pts in the overall study period, were fatigue (3%), constipation (3%), nausea (2%) and insomnia (2%). There were no reports of NEPA-related deaths. Conclusions: Real-life data show that NEPA was effective in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. NEPA had beneficial effects on the quality of life and was highly effective in the acute and delayed phase of HEC and MEC. NEPA antiemetic effectiveness was rated highly both by patients and physicians. Disclosures Karthaus: RIEMSER: Consultancy, Honoraria. Schilling:Riemser: Honoraria.

scholarly journals Chemotherapy-Induced Nausea and Vomiting (CINV) - First Results of a German Non-Interventional Study with NEPA - a Netupitant/Palonosetron Fixed Dose Combination

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3614-3614
Author(s):  
Meinolf Karthaus ◽  
P Klare ◽  
V Heilmann ◽  
G Klausmann ◽  
Joerg Schilling
Keyword(s):  
Quality Of Life ◽  
Complete Response ◽  
Fixed Dose ◽  
Interventional Study ◽  
Phase 0 ◽  
Dose Combination ◽  
Delayed Cinv ◽  
Chemotherapy Efficacy ◽  
Personal Assessment

Abstract Introduction: Platinum and anthracyclin chemotherapy regimens are frequently used in hematology pts and compromised by severe acute and delayed CINV. NEPA, a fixed dose combination of the long lasting NK1-receptor antagonist (RA) netupitant and the pharmacological distinct 5HT3-RA palonosetron, has been approved by FDA and EMA for the prevention of acute and delayed CINV receiving highly emetogenic cisplatin- and AC-based as well as moderately emetogenic chemotherapy. A German non-interventional study is currently investigating NEPA's efficacy and impact on quality of life in adult cancer patients by PRO and physicians' personal assessment under real life conditions. Objectives: Primary objective is to evaluate quality of life (QoL) in adult patients receiving NEPA for CINV prevention. Secondary endpoints are efficacy and safety of NEPA. Methods: This open label, non-interventional, prospective, national, multicenter study evaluates CINV prevention and patients' QoL with NEPA in 2,500 pts receiving either highly or moderately emetogenic cytostatics on up to 2 consecutive days. NEPA is prescribed in accordance with the EU marketing authorization. QoL is evaluated by the validated FLIE questionnaire for 3 chemotherapy cycles 24 hours before, within 24 hours after and additional 4 days after chemotherapy. Efficacy is documented via patient diaries for the same time period. Safety and physicians' overall satisfaction is reported via eCRF. The interim analysis reports on the first 20% of the pre-planned number of patients. Results: Between June 2015 and July 2016 a total of 583 patients were enrolled. Median age was 56 (range of 28-88) with 521 out of 583 patients that completed documentation. A total of 291 patients (56%) received AC-based chemotherapy. Efficacy, evaluated by physicians' personal assessment on a 4-point scale, was rated very good or good for 486 (90.7%), 409 (93.4%) and 350 (92.9%) patients in cycle 1, 2 and 3, respectively. Complete response was analyzed based on 87 completed patient diaries. Here, 88.5% reported no emesis and no rescue medication in the acute phase (0-24h post chemotherapy), while 85.1% and 79.3% reported complete response in the delayed (>24-120h post chemotherapy) and overall phase (0-120h post chemotherapy). A high percentage of patients did not suffer from any emesis (94%, 99% and 93% in acute, delayed and overall phase). The study is ongoing. Conclusions: NEPA proved to be highly effective for prevention of chemotherapy-induced emesis and nausea. Patient reported outcome was rated very good or good in more than 90% of Ctx cycles in the acute as the delayed phase of highly and moderately emetogenic Ctx including cisplatin or anthracyclin based therapy. Disclosures Karthaus: HELSINN: Honoraria; RIEMSER: Honoraria. Schilling:RIEMSER: Honoraria.

scholarly journals Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience

2021 ◽  
Vol 10 (9) ◽  
pp. 1852
Author(s):  
Gry Assam Taarnhøj ◽  
Henriette Lindberg ◽  
Christoffer Johansen ◽  
Helle Pappot
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Life Experience ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Real Life ◽  
Oncological Treatment ◽  
Patient Reported

Patients with urothelial cell carcinoma (UCC) often have comorbidities, which cause trouble for the completion of oncological treatment, and little is known about their quality of life (QoL). The aim of the present study was to obtain and describe patient-reported outcomes (PRO) and QoL data from UCC patients in the treatment for locally advanced muscle-invasive or metastatic UCC. A total of 79 patients with UCC completed four questionnaires (EORTC QLQ-C30, QLQ-BLM30, HADS, and select PRO-CTCAE™ questions) once weekly during their treatment. From those, 26 patients (33%) underwent neoadjuvant treatment for local disease while 53 patients (67%) were treated for metastatic disease. Of all patients, 54% did not complete the planned treatment due to progression, nephrotoxicity, death, or intolerable symptoms during treatment. The five most prevalent PRO-CTCAE grade ≥ 2 symptoms were frequent urination (37%), fatigue (35%), pain (31%), dry mouth (23%), and swelling of the arms or legs (23%). The baseline mean overall QoL was 61 (±SD 24) for all patients (neoadjuvant (73, ±SD 19) and metastatic (54, ±SD 24)) and remained stable over the course of treatment for both groups. A stable overall QoL was observed for the patients in this study. More than half of the patients did not, however, complete the planned treatment. Further supportive care is warranted for bladder cancer patients.

scholarly journals A New Curcuma Extract (Flexofytol®) in Osteoarthritis: Results from a Belgian Real-Life Experience

2014 ◽  
Vol 8 (1) ◽  
pp. 77-81 ◽  
Author(s):  
Thierry Appelboom ◽  
Nathalie Maes ◽  
Adelin Albert
Keyword(s):  
Quality Of Life ◽  
Patient Satisfaction ◽  
Observational Study ◽  
Life Experience ◽  
Real Life ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Patient Pain ◽  
Inflammatory Drugs

This retrospective observational study summarizes the experiences of 820 patients treated with a new Curcuma extract (Flexofytol®, 4-6 capsules per day), for more than 6 months for various forms of painful osteoarthritis. These experiences were reported by 110 Belgian general practitioners via a questionnaire that included quality-of-life parameters for assessing patient experience. Data were submitted to an independent statistician for analysis. Within the first 6 weeks, Flexofytol® improved patient pain, articular mobility, and quality of life. Excellent tolerance was reported, and more than half of these patients were able to discontinue analgaesic and anti-inflammatory drugs. Patient satisfaction was confirmed by their decision to maintain Flexofytol® therapy for more than 6 months. These data must be confirmed with randomized controlled studies. We currently conclude that Flexofytol® which is based on a new preparation of curcumin, is as a potential neutraceutical for the care of patients complaining of joint problems, with excellent tolerance and rapid benefits for articular mobility, pain, and quality of life.

scholarly journals Real-life experience of quality of life, treatment satisfaction, and adherence in patients receiving oral anticoagulants for atrial fibrillation

2018 ◽  
Vol Volume 12 ◽  
pp. 79-87 ◽  
Author(s):  
Michaël Benzimra ◽  
Béatrix Bonnamour ◽  
Martin Duracinsky ◽  
Christophe Lalanne ◽  
Jean-Pierre Aubert ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Treatment Satisfaction ◽  
Life Experience ◽  
Oral Anticoagulants ◽  
Real Life

Immunotherapy discontinuation and outcome: A multicenter real-life experience.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14075-e14075
Author(s):  
Maria Bassanelli ◽  
Diana Giannarelli ◽  
Maria RITA Migliorino ◽  
Marco Russano ◽  
Alain Gelibter ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Progressive Disease ◽  
Life Experience ◽  
Checkpoint Inhibitors ◽  
Real Life ◽  
Progression Free Survival ◽  
Complete Response ◽  
Response To Treatment ◽  
Best Response ◽  
Programmed Death

e14075 Background: Unlike chemotherapy, the optimum treatment duration with Immune checkpoint inhibitors (ICIs) is not clearly established. The aim of this study was to assess the outcome of patients (pts) who discontinued immune-based therapies for any reason except progressive disease. Methods: We conducted an observational, retrospective analysis of 46 consecutive pts with advanced cancer who received ICIs as clinically indicated, at eight Italian institutions. Tumor response to treatment was defined according to RECIST. Median overall survival (OS) and the 95% confidence interval (CI) were estimated with the Kaplan -Meier method. Results: 46 pts (median age 68 years [range 41-86]; male: 65.2%) with advanced cancer (n.39 non-small-cell lung cancer, n.15 renal cell carcinoma and n.2 melanoma) were treated with ICIs: 44 pts received programmed death 1 (PD-1) inhibitors (n.31 nivolumab, n.13 pembrolizumab) and 2 pts programmed death ligand 1 (PD-L1) (n.1 durvalumab, n.1 atezolizumab). A median of 8 cycles were administered [range 1 to 52]. 36 pts discontinued ICIs due to toxicities (diarrhoea, pneumonitis, hepatotoxicity) and 10 pts for reasons non immune-related. The median progression free survival (PFS) from the beginning of ICIs was 12.4 months (mo) [95% CI: 8.2-16.6] and the median OS was 20.0 mo (95% CI: 11.8-28.2). Median PFS from discontinuation of therapy was 5.0 mo [95% CI: 2.7-7.3] and median OS was 16.1 mo (95% CI: 5.4-26.8). Best response achieved according RECIST criteria were: 1 complete response (CR), 18 partial response, 21 stable disease (SD), 2 progressive disease (PR) and 3 non evaluable (NE). During interruption of ICIs 1 pts achieved a PR. Conclusions: This study shows the activity of ICIs, in terms of outcome and durable immune-response, in pts with advanced cancer even after treatment discontinuation.

scholarly journals ASSESSMENT OF TECHNICAL POSSIBILITIES FOR PRODUCTION OF PK- TYPE TERMINALS FOR SEPARATE RAIL FASTENING OF THE RAILWAY TRACK

2021 ◽  
pp. 74-82
Author(s):  
Mykolai Bahrov ◽  
Keyword(s):  
Life Experience ◽  
Real Life ◽  
National Standards ◽  
Railway Track ◽  
Product Certification ◽  
Stable Production ◽  
Certification Procedure ◽  
Certification Body ◽  
The Stability

The availability of the production certificate gives an advantage to any company that cares about improving the efficiency of processes and quality of work. The production certificate is first of all necessary for the enterprises which plan to take partin tenders for supply of products for railway transport and its infrastructure. The production certification procedure involves checking the compliance of regulatory, technological, metrological support, personnel qualification level, organizational arrangements aimed at ensuring the stability of quality indicators of products or services provided, assessment of technical capabilities of the applicant company to ensure stable production/services that meet the requirements of current regulations in Ukraine (national standards, enterprise standards, etc.). Therefore, the assessment of the technical capabilities of the manufacturer, including PC-type terminals of separate rail fastening of the railway track, is the main and integral part of the production certification process. The information and data provided in this paper are based on the real-life experience of the certification body and relate to the quantitative assessment of the technical capabilities of the enterprise that manufactures PK-type terminals. Key words: product certification, assessment of technical capabilities, production certificate, certification body, technological accuracy reserve.

A prospective analysis of chemotherapy-induced nausea and vomiting in gastrointestinal cancers: Results from a tertiary cancer center.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12111-12111
Author(s):  
Akhil Kapoor ◽  
Vikas S. Ostwal ◽  
Anant Ramaswamy ◽  
Prabhat Ghanshyam Bhargava ◽  
Sudeep Gupta ◽  
...  
Keyword(s):  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Cancer Center ◽  
Gastrointestinal Cancers ◽  
Eligibility Criteria ◽  
Tract Cancer ◽  
Antiemetic Prophylaxis ◽  
Common Diagnosis ◽  
Delayed Cinv

12111 Background: Chemotherapy-induced nausea and vomiting (CINV) is a bothersome side-effect associated with cancer chemotherapy which adversely impacts both quality of life and the ability to carry out the activities of daily living. This study was conducted to assess the proportion of patients developing CINV after receiving chemotherapy for gastrointestinal (GI) cancers, in spite of receiving antiemetic prophylaxis as per the standard guidelines. Methods: Consecutive patients with GI malignancy who had not received previous chemotherapy were eligible for enrollment in the study if they were scheduled to receive at least one cycle of chemotherapy. SPSS version 20 was used for all statistical calculations. Results: 701 patients fulfilling the eligibility criteria were included in this study, out of which 55.4% were males, median age was 51 years (range 22-77). Biliary tract cancer (34%) was the most common diagnosis followed by colorectal (30.2%) and gastric cancer (19.6%). As per MASCC guidelines, 22.1% patients received highly emetogenic chemotherapy, 56.0% moderately emetogenic chemotherapy (MEC) while 19.9% received regimen with low emetogenicity. Failure to achieve complete response (CR, absence of acute and delayed CINV) was found in 27.4% patients. On separately analysing MEC group, overall CR was not achieved in 33.8% with failure in acute settings in 17.8% and delayed in 16.0% patients. Only significant factor for not achieving CR was use of oxaliplatin based chemotherapy (p = 0.018 for acute and p = 0.014 for delayed CINV). Conclusions: More than one fourth patients failed to achieve complete response for CINV in gastrointestinal cancers despite using prophylaxis as per standard guidelines. Use of oxaliplatin based therapy is an important factor for MEC causing CINV. There is urgent need to update the guidelines for prophylaxis in this setting. [Table: see text]

scholarly journals A Randomized, Double-Blind Pilot Study of Dose Comparison of Ramosetron to Prevent Chemotherapy-Induced Nausea and Vomiting

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Ka-Rham Kim ◽  
Gaeun Kang ◽  
Myung-Seo Ki ◽  
Hyun-Jeong Shim ◽  
Jun-Eul Hwang ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Optimal Dose ◽  
Complete Response ◽  
Dose Titration ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Double Blind ◽  
Dose Comparison ◽  
Subsequent Cycle ◽  
Delayed Cinv ◽  
Acute Cinv

Purpose. This study was conducted to determine the optimal dose titration of ramosetron to prevent the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).Methods. Patients treated with folic acid, 5-fluorouracil, and oxaliplatin were randomized into three groups (0.3 mg, 0.45 mg, and 0.6 mg ramosetron before chemotherapy). The pharmacokinetics and pharmacodynamics using RINVR were evaluated.Results. Seventeen, 15, and 18 patients received ramosetron at doses of 0.3 mg, 0.45 mg, and 0.6 mg, respectively.Tmax(h),Cmax(ng/mL), andAUClast(ng·h/mL) were associated with dose escalation significantly, showing a reverse correlation with the RINVR during chemotherapy. Acute CINV was observed in four patients (22.2%), two patients (14.3%), and one (5.6%) patient and a delayed CINV on day 7 was found in eight (47%), three (21.4%), and five (27.8%) patients in each group. The complete response rate was increased with dose escalation (35.3%, 50.0%, and 72.2% in each group) and also showed the tendency for decreasing moderate-to-severe CINV.Conclusions. This study shows a trend regarding the dose-response relationship for ramosetron to prevent CINV, including delayed emesis. It suggested that dose escalation should be considered in patients with CINV in a subsequent cycle of chemotherapy, and an individual approach using RINVR could be useful to monitor CINV.

A unique schedule of palonosetron, ondansetron, and dexamethasone for the prevention of delayed nausea and vomiting in patients receiving myeloablative chemotherapy

2018 ◽  
Vol 25 (6) ◽  
pp. 1336-1342
Author(s):  
J LaPorte ◽  
K Leone ◽  
X Zhang ◽  
K Holland ◽  
L Morris ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Phase Ii Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Myeloablative Chemotherapy ◽  
Delayed Nausea ◽  
Delayed Cinv ◽  
The Mean ◽  
Nausea Severity

Myeloablative chemotherapy administered prior to autologous stem cell transplantation (auto-SCT) is associated with a significant amount of chemotherapy-induced nausea and vomiting (CINV). We conducted a phase II trial to assess the safety, efficacy, and impact on quality of life when palonosetron (PAL) 0.25 mg combined with dexamethasone were given on the final or only day of myeloablative chemotherapy for auto-SCT. The primary end point of this study was the incidence of achieving a delayed CINV complete response defined as no emetic episode and no use of rescue medications during the 24–120 h period post chemotherapy. Eighty-five patients were enrolled in the study and received PAL. A delayed CINV complete response was achieved in 15% of patients. A multivariate analysis demonstrated no associated differences between age, gender, diagnosis, or regimen. By day 5 after PAL, the mean nausea severity was 0.91 ± 2.45 vs. 0.09 ± 1.58 at baseline (p = 0.012). Quality of life measurements demonstrated similar quality of life between baseline and day 3. By day 6 however, nausea alone had a statistically significant impact on quality of life. In our study, PAL controlled nausea severity and sustained quality of life, but further strategies are needed to control delayed CINV associated with the auto-SCT process.

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