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Systemic Therapy Update Systemic Therapy Update Volume 24 Issue 2 February 2021 For Health Professionals Who Care for Cancer Patients Inside This Issue: Editor’s Choice Revised Protocols, PPPOs and Patient Handouts COVID-19 Vaccine Guidance | New Programs: Ribociclib BR: BRAJACT, BRAJACTG, BRAJACTT, BRAJACTTG, BRAJACTW, BRAJCAP, and Fulvestrant for Advanced Breast Cancer BRAJLHRHAI, BRAJLHRHT, BRAJTTW, BRAVCAP, BRAVCLOD, BRAVEVEX, (UBRAVRBFLV) | Bevacizumab, Cisplatin and Paclitaxel for BRAVGEMT, BRAVLCAP, BRAVLHRHA, BRAVLHRHT, UBRAVPALAI, BRAVPTRAT, Gynecologic Malignancies (GOCISPBEV) | Gemtuzumab UBRAVRIBAI, BRAVTAX, BRAVTCAP, BRAVTW, BRLACTWAC, BRLATACG, BRLATWAC | GI: GIAAVCT, GIAJCAP, GIAJCAPOX, GIAJFFOX, GIAJRALOX, Ozogamicin with Chemotherapy for AML (ULKGEMOZ) | GIAVCAP, GIAVCAPB, GIAVCRT, GIAVTZCAP, GICAPIRI, GICAPOX, GICART, Bortezomib, Lenalidomide and Dexamethasone for GICIRB, GICOXB, GICPART, GIEFFOXRT, GIENACTRT, GIFFIRB, GIFFOXB, Untreated Multiple Myeloma (UMYBLDF) | Paclitaxel for UGIFFOXPAN, GIFIRINOX, GIFOLFOX, GIGAJCOX, GIGAJCPRT, GIGAJFFOX, Metastatic Angiosarcoma (SAAVTW) | Cemiplimab for GIGAVCC, GIGAVCCT, GIGAVCFT, GIGAVCOX, GIGAVCOXT, GIGAVFFOX, Cutaneous Squamous Cell Carcinoma (USMAVCEM) GIGAVFFOXT, GIGAVRAMT, GIGECC, GIGFLODOC, UGINETEV, GIPAJFIROX, GIPAJGCAP, GIPAVCAP, GIPNEVER, GIRAJCOX, GIRAJFFOX, GIRCAP, GIRCRT, Drug Update GIRINFRT | GO: GOCABR, GOCABRBEV, GOCISP, GOCXAJCAT, GOCXCAT, IV Famotidine to Replace IV Ranitidine GOCXCATB, GOCXCRT, GOENDCAT, GOOVBEVLD, GOOVBEVP, GOOVCATB, Medication Safety Corner GOOVCATM, GOOVCATR, GOOVCATX, GOOVDDCAT, GOOVDOC, GOOVETO, GOOVFPLDC, GOOVIPPC, GOOVLDOX, GOOVPLDC, GOOVTAX3 | GU: GUCABO, Oral Medication Auxiliary Administration Information GUEVER, GUFUPRT, UGUPABI, GUPAZO, GUPCABA, GUPLHRH, GUTAXGEM, © Cancer Drug Manual GUTIP | HN: HNAVCAP, HNAVFUP, HNAVPC, HNLACART, HNNAVCAP, New: Darolutamide, Tislelizumab | Revised: Cemiplimab, HNNAVFUP, HNNAVPC, HNOTLEN, HNOTVAN, HNSAVFUP | LK: ULKCMLB, Dactinomycin, Durvalumab, Fulvestrant, Gemtuzumab ULKCMLN | LU: LUAJPC, LUAVAFAT, LUAVALE, ULUAVCER, LUAVPC, ULUAVPCPMB, LULACATRT, ULUNETEV | LY: HLHETCSPA, LYCHLOR, LYCHLRR, Ozogamicin, Temsirolimus LYCHOP, LYCHOPR, LYCHOPRMTX, LYCHPBV, LYCLLBENDR, LYCLLCHLR, Benefit Drug List LYCLLCVPR, LYCLLFLUDR, LYCVP, LYCVPPABO, LYCVPR, LYCYCLO, LYEPOCHR, New Programs: UBRAVRBFLV, GOCISPBEV, ULKGEMOZ, LYFCR, LYFLU, LYFLUDR, LYGDP, LYGDPR, LYMFBEX, LYOBCHLOR, ULYVENETO, UMYBLDR, SAAVTW, USMAVCEM LYVENETOR | MY: MYBORPRE, MYBORREL, UMYDARBD, UMYDARLD, MYMPBOR, MYPAM, MYZOL | PU: PUCAT | SA: SAAVGEMD, SAAVGI, SAVDC | New Protocols, PPPOs and Patient Handouts SC: SCDRUGRX, SCOXRX BR: UBRAVRBFLV | GO: GOCISPBEV | LK: ULKGEMOZ | MY: UMYBLDR | SA: SAAVTW | SM: USMAVCEM Resources and Contact Information Editor’s Choice COVID-19 Vaccine Guidance The BC Cancer Guidance on COVID-19 Vaccines in Patients with Cancer is available on the BC Cancer website in the COVID-19 Resources section under the Vaccine Guidelines sub-menu. The guidance is for adult patients with cancer or undergoing cancer therapy, and includes information on: • Recommendations for immunization with COVID-19 vaccines • Efficacy and safety of COVID-19 vaccines • Suggested timing for immunization with the COVID-19 vaccine in relation to different cancer therapies, including: immunosuppressive therapy, hormonal therapy, targeted therapy, checkpoint inhibitor immunotherapy and radiation therapy BC Cancer | Provincial Systemic Therapy Program Update | Volume 24 Issue 2 | February 2021 | Page 1 Editor’s Choice New Programs The BC Cancer Provincial Systemic Therapy Program has approved the following new treatment programs effective 01 February 2021. The full details of these programs can be found on the BC Cancer website in the Chemotherapy Protocols section. Breast Ribociclib and Fulvestrant with or without LHRH Agonist for Advanced Breast Cancer (UBRAVRBFLV) — The BC Cancer Breast Tumour Group is implementing combination therapy with ribociclib, a CDK 4/6 inhibitor, and fulvestrant, an estrogen receptor antagonist, in patients with advanced breast cancer. Eligible patients include post-menopausal women and men with ER-positive, HER2-negative advanced breast cancer with metastatic disease, including women with chemically induced menopause using a LHRH agonist. Note that the eligibility criteria for UBRAVRIBAI (ribociclib and aromatase inhibitor) have been expanded. Please consult the UBRAVRBFLV and UBRAVRIBAI protocols for full eligibility details. BC Cancer Compassionate Access Program (CAP) approval is required for each of the treatment programs. Approval for this new treatment program is based on the phase III MONALEESA-3 trial of ribociclib in combination with fulvestrant in post-menopausal women and men with HR-positive, HER2-negative advanced breast cancer.1,2 Patients were randomized to ribociclib or placebo, both on a background of fulvestrant. Eligible patients may have received up to one previous line of endocrine therapy for advanced breast cancer. After a median follow-up of 39.4 months, the median progression-free survival (mPFS) was significantly improved in the ribociclib group (20.6 months vs. 12.8 months, HR 0.59, 95% CI 0.49-0.71). Grade 3 or 4 adverse events occurred in 78% of patients treated with ribociclib and 30% of patients treated with placebo. Common adverse events that occurred with greater frequency in the ribociclib group include neutropenia (70% vs. 2%), nausea (45% vs. 28%), leukopenia (28% vs. 2%), vomiting (27% vs. 13%), constipation (25% vs. 12%), alopecia (19% vs. 5%) and anemia (17% vs. 5%). Gynecologic Bevacizumab, Cisplatin and Paclitaxel as Alternative Treatment for Gynecological Malignancies (GOCISPBEV) — This treatment program is for use in patients who are eligible to receive combination therapy with bevacizumab-carboplatin-paclitaxel, but have experienced non-life threatening infusion- related reactions with carboplatin. After switching to the cisplatin-containing regimen, patients should complete the total number of cycles specified in their original carboplatin-containing protocol (i.e., GOOVCATB or GOCXCATB). Patients continuing on maintenance bevacizumab for ovarian cancer should use GOOVCATB. Leukemia Gemtuzumab Ozogamicin with Induction and Consolidation Chemotherapy for Acute Myeloid Leukemia (ULKGEMOZ) — The BC Cancer Leukemia and Bone Marrow Transplant Tumour Group is introducing gemtuzumab ozogamicin for patients with newly diagnosed CD33-positive acute myeloid leukemia (AML). Gemtuzumab ozogamicin is an antibody-drug conjugate targeting the CD33 receptor expressed on cells of myeloid origin including the majority of AML blasts.3 In this treatment regimen, gemtuzumab ozogamicin is used in combination with standard cytarabine and daunorubicin induction and consolidation chemotherapy. This therapy is delivered at Vancouver General Hospital under the direction of the Leukemia/BMT program. BC Cancer Compassionate Access Program (CAP) approval is required. BC Cancer | Systemic Therapy Update | February 2021 | Page 2 Editor’s Choice Approval of gemtuzumab ozogamicin for patients with previously untreated AML is based on the phase III ALFA-0701 trial.4 The addition of gemtuzumab ozogamicin to standard induction and consolidation chemotherapy significantly improved 2-year event-free survival (EFS) and 2-year overall survival (OS) (EFS: 40.8% vs. 17.1%, HR 0.58, 95% CI 0.43-0.78; OS: 53.2% vs. 41.9%, HR 0.69, 95% CI 0.49-0.98). More information about the pharmacology and adverse effects of gemtuzumab ozogamicin can be found in the Cancer Drug Manual section of the September 2020 issue of the Systemic Therapy Update. Myeloma Bortezomib, Lenalidomide and Dexamethasone for Previously Untreated Multiple Myeloma (UMYBLDF) — The BC Cancer Lymphoma and Myeloma Tumour Group is implementing the combination of bortezomib-lenalidomide-dexamethasone as initial therapy in patients who are considered ineligible for autologous stem cell transplantation. BC Cancer Compassionate Access Program (CAP) approval is required. Patients with significant frailty or comorbidity may still be treated with the lenalidomide- dexamethasone (UMYLDF) or bortezomib-alkylating agent combination (MYMPBOR) treatment protocols. Approval for this treatment program is based on the phase III SWOG S0777 trial in newly-diagnosed patients with multiple myeloma.5,6 Patients were randomized to receive eight cycles of twice-weekly bortezomib in combination with lenalidomide-dexamethasone, or lenalidomide-dexamethasone alone. Patients in both groups received lenalidomide-dexamethasone until disease progression. Treatment with bortezomib was associated with a statistically significant improvement in median progression-free survival (mPFS) and median overall survival (mOS) (mPFS: 43 months vs. 30 months, HR 0.712, 95% CI 0.56-0.906; mOS: 75 months vs. 64 months, HR 0.709, 95% CI 0.524-0.959). Similar rates of grade 3 or greater hematological toxicity were reported in the treatment groups (46% vs. 45%). Higher rates of grade 3 or greater neuropathy and gastrointestinal toxicity were reported in the bortezomib group (33% vs. 11% and 22% vs. 8%, respectively); lower rates of both toxicities are expected with the modified weekly bortezomib dosing regimen used in UMYBLDF, based on a favourable adverse event profile with the modified dosing regimen in an open-label study.7 Sarcoma Weekly Paclitaxel for Metastatic or Unresectable Angiosarcoma (SAAVTW) — The BC Cancer Sarcoma Tumour Group is implementing weekly paclitaxel as first-line therapy for patients
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