Gynaecology SACT Regimens

The information contained in these regimens is a statement of consensus of NCCP and ISMO or IHS professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. The treatment regimen to be used should take into account factors such as histology, molecular pathology, age, performance status, co-morbidities and the patient’s preference. Each treatment regimen has advantages and disadvantages, and there may be more than one good option. In addition, treatment choices can change over time as more evidence becomes available. Use of these documents is the responsibility of the prescribing clinician and is subject to the HSE.ie terms of use.

NCCP Guidance on bevacizumab rapid infusion rate (PDF)

Please email any comments or feedback on these regimens to oncologydrugs@cancercontrol.ie.

Information on testing to inform PARP inhibitor cancer treatment is available here

For information on open clinical trials please refer to the Cancer Trials Ireland website here and also to basket trials here.

Regimens
Regimen Name	Indication
CARBOplatin (AUC 2) Weekly with Radiotherapy (RT) Regimen	00419b Chemoradiation treatment in locally advanced cervical cancer when CISplatin is contraindicated or not tolerated.
CISplatin 40mg/m² Weekly with Radiotherapy (RT) Regimen	00385a Chemoradiation treatment for locally advanced (stage IIB to IVA) cervical squamous cell carcinoma (SCC).
CISplatin (75mg/m2) + Etoposide (100mg/m2) + Radiotherapy (RT) - 21 day Regimen	00279b Small cell cancer of the cervix and other sites
Bevacizumab 15mg/kg, PACLitaxel 175mg/m2 and CISplatin 50mg/m2 Therapy Regimen	00799a Locally advanced metastatic or recurrent or metastatic cervical cancer, not amenable to curative surgery or radiation therapy
Cemiplimab Therapy Regimen	00812a As monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy
Pembrolizumab 200mg Monotherapy Regimen	00455j As monotherapy for the treatment of recurrent, or metastatic cervical cancer with disease progression on or after chemotherapy in adults whose tumours express PDL1 with a CPS ≥ 1i
Pembrolizumab 400mg Monotherapy Regimen	00558j As monotherapy for the treatment of recurrent, or metastatic cervical cancer with disease progression on or after chemotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1i
Pembrolizumab, PACLitaxel 175mg/m2 , CARBOplatin AUC 5 and Bevacizumab Therapy Regimen	00811a Treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥ 1
Pembrolizumab, PACLitaxel 175mg/m2 and CARBOplatin AUC 5 Therapy Regimen	00817a Treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥ 1

Gestational Trophoblastic Neoplasia (GTN)

Regimen Name	Indication
DACTINomycin Therapy Regimen	00247a Alternative treatment of low risk gestational trophoblastic disease (GTD) (risk score ≤ 6)
EMA/CO Therapy (Etoposide, Methotrexate, DACTINomycin, Cyclophosphamide, vinCRIStine) Regimen	00248a Treatment of high risk gestational trophoblastic neoplasia (GTN) (FIGO score ≥7). 00248b Treatment of patients with low risk GTN who have not responded or have relapsed from single agent chemotherapy (methotrexate or actinomycin D).
Two Day Etoposide CISplatin (EP) Therapy Regimen	00267a Emergency treatment of women with Gestational Trophoblastic Neoplasia (GTN) who are acutely unwell from liver or CNS disease and particularly those at risk of respiratory failure. 00267b Hepatic Metastases. Women with GTN who are acutely unwell from liver disease. 00267c Cerebral Metastases. Women with GTN who are acutely unwell from cerebral metastases.
EMA/EP Therapy (Etoposide Methotrexate DACTINomycin/Etoposide CISplatin) Regimen	00264a Treatment of women with high-risk Gestational Trophoblastic Neoplasia (GTN) who have not responded or have relapsed from treatment with EMA/CO. 00264b GTN and hepatic metastases. Women with GTN and hepatic metastases at presentation.
Intrathecal Methotrexate for CNS prophylaxis in GTN Regimen	00249a Central nervous system (CNS) prophylaxis in patients with high risk gestational trophoblastic neoplasia (GTN). 00249b Central nervous system (CNS) prophylaxis in patients with low risk gestational trophoblastic neoplasia (GTN) with lung metastases.
Methotrexate 8 day Charing Cross Regimen Regimen	00246a Treatment of low risk gestational trophoblastic disease (GTD) (FIGO score ≤ 6).
PACLitaxel/Etoposide alternating with PACLitaxel/CISplatin (TE/TP) Therapy Regimen	00266a Treatment of women with high-risk Gestational Trophoblastic Neoplasia (GTN) who have not responded or have relapsed from treatment with EMA/CO.

Regimen Name

Indication

DACTINomycin Therapy

Regimen

00247a

Alternative treatment of low risk gestational trophoblastic disease (GTD) (risk score ≤ 6)

EMA/CO Therapy (Etoposide, Methotrexate, DACTINomycin, Cyclophosphamide, vinCRIStine)

Regimen

00248a

Treatment of high risk gestational trophoblastic neoplasia (GTN) (FIGO score ≥7).

00248b

Treatment of patients with low risk GTN who have not responded or have relapsed from single agent chemotherapy (methotrexate or actinomycin D).

Two Day Etoposide CISplatin (EP) Therapy

Regimen

00267a

Emergency treatment of women with Gestational Trophoblastic Neoplasia (GTN) who are acutely unwell from liver or CNS disease and particularly those at risk of respiratory failure.

00267b

Hepatic Metastases.
Women with GTN who are acutely unwell from liver disease.

00267c

Cerebral Metastases.
Women with GTN who are acutely unwell from cerebral metastases.

EMA/EP Therapy (Etoposide Methotrexate DACTINomycin/Etoposide CISplatin)

Regimen

00264a

Treatment of women with high-risk Gestational Trophoblastic Neoplasia (GTN) who have not responded or have relapsed from treatment with EMA/CO.

00264b

GTN and hepatic metastases. Women with GTN and hepatic metastases at presentation.

Intrathecal Methotrexate for CNS prophylaxis in GTN

Regimen

00249a

Central nervous system (CNS) prophylaxis in patients with high risk gestational trophoblastic neoplasia (GTN).

00249b

Central nervous system (CNS) prophylaxis in patients with low risk gestational trophoblastic neoplasia (GTN) with lung metastases.

Methotrexate 8 day Charing Cross Regimen

Regimen

00246a

Treatment of low risk gestational trophoblastic disease (GTD) (FIGO score ≤ 6).

PACLitaxel/Etoposide alternating with PACLitaxel/CISplatin (TE/TP) Therapy

Regimen

00266a

Treatment of women with high-risk Gestational Trophoblastic Neoplasia (GTN) who have not responded or have relapsed from treatment with EMA/CO.

**Ovarian Chemotherapy Regimens**
Bleomycin, Etoposide and CISplatin (BEP) Therapy Regimen	00300a Adjuvant treatment of high risk (vascular invasion carcinoma) stage 1 nonseminoma germ cell tumour. 00300b Metastatic germ cell tumours of the testis. 00300c Advanced stage or metastatic germ cell tumours (dysgermimoma) of the ovaries. 00300d Extra-gonadal germ cell tumours.
Bevacizumab 10mg/kg Therapy-14 day Regimen	00212b In combination with paclitaxel, topotecan (given weekly), or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
Bevacizumab 15mg/kg, CARBOplatin (AUC 6) and PACLitaxel 175mg/m2 Therapy Regimen	00766a For the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer
Bevacizumab 15mg/kg Therapy-21 day Regimen	00215a In combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. 00215c In combination with, topotecan given on days 1-5 every 3 weeks*, for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
Bevacizumab 10mg/kg and Pegylated liposomal DOXOrubicin 40mg/m2 Therapy Regimen	00772a For the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Bevacizumab 7.5mg/kg, CARBOplatin (AUC5) and PACLitaxel 175mg/m2 Therapyⁱ Regimen	00620a Bevacizumab in combination with CARBOplatin and PACLItaxel is indicated as first line post-surgical treatment in FIGO stage III after surgery with residual disease ≥1cm or FIGO stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Bevacizumab 10mg/kg and PACLitaxel 80mg/m2 (Day 1, 8, 15 and 22) Therapy Regimen	00769 For the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
Bevacizumab 10mg/kg and Topotecan 4mg/m2 Therapy Regimen	00771 For the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
Bevacizumab 15mg Paclitaxel and CARBOplatin AUC 5 Regimen	00716a Bevacizumab in combination with CARBOplatin and PACLitaxel for the treatment of persistent recurrent or metastatic cervical cancer, not amenable to curative surgery or radiation therapy
CARBOplatin (AUC 4-6) Monotherapy- 28 day Regimen	First line adjuvant therapy of 00251a ovarian carcinoma of epithelial origin 00251b primary peritoneal carcinoma 00251c fallopian tube cancer where combination therapy is not suitable.
CARBOplatin (AUC 4-6) Monotherapy- 28 day Regimen	First line therapy of advanced Stage 3 and 4 00251d ovarian carcinoma of epithelial origin 00251e primary peritoneal carcinoma 00251f fallopian tube cancer where surgery is not feasible and where combination therapy is not suitable.
CARBOplatin (AUC 4-6) Monotherapy- 28 day Regimen	Treatment of recurrent, platinum-sensitive, 00251g invasive ovarian carcinoma of epithelial origin 00251h primary peritoneal carcinoma 00251i fallopian tube cancer
CARBOplatin (AUC 4-6) Monotherapy- 21 day Regimen	First line adjuvant therapy of 00261a ovarian carcinoma of epithelial origin 00261b primary peritoneal carcinoma 00261c fallopian tube cancer where combination therapy is not suitable.
CARBOplatin (AUC 4-6) Monotherapy- 21 day Regimen	First line therapy of advanced Stage 3 and 4 00261d ovarian carcinoma of epithelial origin 00261e primary peritoneal carcinoma 00261f fallopian tube cancer where surgery is not feasible and where combination therapy is not suitable.
CARBOplatin (AUC 4-6) Monotherapy- 21 day Regimen	Treatment of recurrent, platinum-sensitive, 00261g invasive ovarian carcinoma of epithelial origin 00261h primary peritoneal carcinoma 00261i fallopian tube cancer.
CARBOplatin (AUC5-7.5) and PACLitaxel 175mg/m2 Therapy Regimen	00303a Adjuvant treatment of high risk, stage I, epithelial ovarian cancer* 00303b Treatment of advanced ovarian cancer 00303c Treatment of primary peritoneal cancer 00303d Treatment of fallopian tube cancer 00303e Treatment of recurrent or advanced endometrial cancer (stage III or IV) * 00303f Treatment of advanced/recurrent non small cell (NSC)cancer of the cervix^* 00303g Treatment of carcinoma of unknown primary site^*
CARBOplatin (AUC 6) and Weekly PACLitaxel 80mg/m² Therapy Regimen	00308a Adjuvant treatment of high risk, stage I, epithelial ovarian cancer* 00308b Treatment of advanced ovarian cancer* 00308c Treatment of primary peritoneal cancer* 00308d Treatment of fallopian tube cancer*
Carboplatin AUC 5 and Pegylated Liposomal DOXOrubicin 30mg/m2 Therapy-28 day Regimen	00624a Treatment of patients with platinum sensitive relapsed/ recurrent ovarian cancer. 00624b Treatment of patients with platinum sensitive relapsed/ recurrent primary peritoneal cancer. 00624c Treatment of patients with platinum sensitive relapsed/ recurrent fallopian tube cancer.
CISplatin (50mg/m2 ) Chemoradiation followed by CARBOplatin (AUC 5) and PACLitaxel (175mg/m2 ) – Endometrial Cancer Regimen	00676a Adjuvant treatment for high risk, stage I (grade 3 with deep myometrial invasion and/or lymph-vascular invasion) stage II or III endometrial carcinoma or stage I–III endometrial carcinoma with serous or clear cell histology following surgery.
DOCEtaxel Monotherapy 75mg/m² – 21 day cycle Regimen	00203e Treatment of Relapsed/Progressing primary peritoneal carcinoma 00203f Treatment of Relapsed/Progressing Epthelial Ovarian carcinoma 00203g Treatment of Relapsed/Progressing Fallopian Tube Carcinoma
Etoposide and CISplatin 20mg/m² (EP) 5 Day Therapy Regimen	00301a Treatment of good prognosis (IGCCCG criteria) metastatic germ cell tumours (both non-seminoma and seminoma).
Gemcitabine 1000mg/m²and CARBOplatin (AUC 4) Therapy-21 day Regimen	00306a Treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first line therapy. 00306b Treatment of patients with fallopian tube cancer with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first line therapy* 00306c Treatment of patients with primary peritoneal cancer with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first line therapy^*
Gemcitabine(1000mg/m2),CARBOplatin (AUC 4) and Bevacizumab 15mg/kg Therapy- 21 day Regimen	00499a Treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents
Niraparib Monotherapy Regimen	00571a As monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian cancer who are in response (complete or partial response) to platinum-based chemotherapy 00571b As monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed fallopian tube cancer who are in response (complete or partial response) to platinum-based chemotherapy 00571c As monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed primary peritoneal cancer who are in response (complete or partial response) to platinum-based chemotherapy 00571d As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high grade ovarian cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy 00571e As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) fallopian tube cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy 00571f As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
Olaparib (Tablet) and Bevacizumab Therapy Regimen	00746a Olaparib in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.
Olaparib (Tablets) Monotherapy Regimen	00588a Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2‐mutated (germline and/or somatic) high-grade epithelial ovarian cancer who are in response (complete or partial) following completion of first‐line platinum based chemotherapy 00588b Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2‐mutated (germline and/or somatic) fallopian tube cancer who are in response (complete or partial) following completion of first‐line platinum based chemotherapy 00588c Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2‐mutated (germline and/or somatic) primary peritoneal carcinoma who are in response (complete or partial) following completion of first‐line platinum based chemotherapy 00588d Maintenance treatment of adult patients with platinum -sensitive relapsed BRCA-mutated (germline and/or somatic) -high grade serous epithelial ovarian cancer who are in response (complete response or partial response) to platinum-based chemotherapy. 00588e Maintenance treatment of adult patients with platinum -sensitive relapsed BRCA-mutated (germline and/or somatic) fallopian tube cancer who are in response (complete response or partial response) to platinum-based chemotherapy. 00588f Maintenance treatment of adult patients with platinum -sensitive relapsed BRCA-mutated (germline and/or somatic) primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Pegylated Liposomal DOXOrubicin 50mg/m2 - 28 days Regimen Regimen	00205b Treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.
PACLitaxel Monotherapy 80mg/m2 Day 1, 8, 15 and 22 – 28 Day Regimen	00226b* Second-line chemotherapy for metastatic ovarian cancer after failure of standard, platinum-containing therapy.
PACLitaxel 80mg/m2 Day 1, 8 and 15 Monotherapy-28 Day Regimen	00621c Second-line chemotherapy for metastatic ovarian cancer after failure of standard, platinum-containing therapyⁱ
Topotecan Monotherapy-5 day Regimen	00311a Treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy 00311c Treatment of patients with metastatic carcinoma of the fallopian tubes after failure of first-line or subsequent therapy* 00311d Treatment of patients with metastatic peritoneal carcinoma after failure of first-line or subsequent therapy^*
Topotecan Monotherapy-Weekly* Regimen	00312a Treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy 00312b Treatment of patients with metastatic carcinoma of the fallopian tubes after failure of first-line or subsequent therapy 00312c Treatment of patients with metastatic peritoneal carcinoma after failure of first-line or subsequent therapy
Trabectedin and Pegylated Liposomal DOXOrubicin (PLD) Therapy Regimen	00375a Treatment of patients with relapsed platinum-sensitive ovarian cancer.
Intravenous Vinorelbine Therapy-21 days Regimen	00232c* Platinum refractory advanced ovarian carcinoma.

*Unlicensed indication. See regimen for more details.