Source: https://www.eviq.org.au/medical-oncology/melanoma/metastatic/244-melanoma-metastatic-fotemustine-three-weekly-m
Timestamp: 2019-08-20 21:15:27
Document Index: 339376673

Matched Legal Cases: ['art 2', 'art 2', 'art 1', 'art 1', 'art 1', 'art 2']

244-Melanoma metastatic fotemustine three weekly maintenance therapy (part 2) SUPERSEDED | eviQ
ID: 244 v.3
Continuous until disease progression or unacceptable toxicity (this is part 2 of the treatment which follows part 1 after a 5 week break)
Maintenance therapy to follow fotemustine weekly induction therapy for unresectable or metastatic melanoma.
less than 0.5 Delay treatment until recovery and reduce fotemustine by 25% for subsequent cycles
Febrile neutropenia Delay treatment until recovery and reduce fotemustine by 25% for subsequent cycles
80 to less than 100 Delay treatment until recovery
less than 80 Delay treatment until recovery and reduce fotemustine by 25% for subsequent cycles
* Haematological dose modifications according to eviQ Reference Committee consensus on the basis of delayed myelosuppression.
Myelosuppression was the most common adverse event in both treatment arms. Grade 3 and 4 haematological toxicities are shown below.
The most frequent nonhaematological adverse events related to fotemustine therapy were nausea (20%), vomiting (13%), asthenia (4.5%) and reaction at injection site (4.5%). The most frequent nonhaematological adverse events related to DTIC were nausea (17%), vomiting (8%), fever (4%) and headache (4%). Grade 3 and 4 adverse events are shown below.
PBS indication added and minor editing.
Review, new dose modifications and transferred to eviQ (Protocol split into 2 parts, induction therapy and maintenance therapy).
Statement on stability "administer fotemustine within 4 hours of being reconstituted" changed to " the reconstituted solution should be used immediately or as soon as practical ".
Evidence: Clarification of dosing regimen for maintenance treatment with fotemustine i.e. 100 mg/m2 every 3 weeks.
Dose modifications: Dose modifications for haematological toxicity changed as per PI (was previously standard eviQ dose modifications).
Drug interactions: general interaction with antiepileptics removed as per PI.
Protocol reviewed and dose modifications updated at reference committee meeting 27/04/12.
Added in 3 side effects, taste and smell, diarrhoea and alopecia (partial) to match part 1 ID 338, as same single agent drug.
Dose mods clarified from April 2012 RCM as different in part 1 and part 2. ANC to be the same as single agent dacarbazine protocol ID 337 but then change the platelets to cut off of 80 as per PI. To be reviewed at 2018 RCM.
Protocol reviewed at Medical Oncology Reference Committee meeting 15/06/2018.
Group consensus to supersede protocol due to superior alternatives being available. Version number changed to V.3. Next review in 2 years.
https://www.eviq.org.au/p/244