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Second Line Chemotherapy – Phase II Weekly Vinblastine…

This is the next chemotherapy regime Eleanor is currently facing and below are the kind of efficacy studies that have been carried out. This demonstrates what we face when learning about the usefulness of toxins Eleanor will have pumped in to her little body….

Purpose: Vinblastine monotherapy has shown promising activity and a low-toxicity profile in patients with pediatric low-grade glioma (PLGG) who experienced treatment failure after initial treatment with chemotherapy and/or radiation. The aim of this study was to assess the activity of vinblastine in therapy-naïve children. Patients and methods: Patients < 18 years old with unresectable and/or progressive therapy-naïve PLGG were eligible. Vinblastine was administered once per week at a dose of 6 mg/m(2) intravenously over a period of 70 weeks. Vision, quality of life, neurofibromatosis type 1 (NF1) status, and BRAF mutation/fusion status were also determined and correlated with outcome. Results: Fifty-four patients were enrolled onto the study, with a median age of 8 years (range, 0.7 to 17.2 years). Most patients had chiasmatic/hypothalamic tumors (55.5%), and 13 patients (24.1%) had NF1. The most common histology was pilocytic astrocytoma (46.3%). Seventeen patients were diagnosed using radiologic criteria alone. Best response to chemotherapy was centrally reviewed with a response rate (complete, partial, or minor response) of 25.9%. Disease stabilization (complete, partial, or minor response or stable disease) was achieved in 47 patients (87.0%). Visual improvement was observed in 20% of patients with optic pathway glioma. Five-year overall survival and progression-free survival (PFS) rates were 94.4% (95% CI, 88.5% to 100%) and 53.2% (95% CI, 41.3% to 68.5%), respectively, for the entire cohort. Patients with NF1 had a significantly better PFS (85.1%; 95% CI, 68.0% to 100%) when compared with patients without NF1 (42.0%; 95% CI, 29.1% to 60.7%; P = .012). Age< 3 years or > 10 years was not associated with poor outcome. Treatment was well tolerated, and quality of life was not affected during treatment. In this trial, there was no correlation between BRAF alterations and outcome. Conclusion: Vinblastine administered once per week is well tolerated in children with treatment naïve PLGG. Overall survival and PFS are comparable to current therapies, with a favorable toxicity profile and a maintained quality of life.

 

Eleanor began this 52 week protocol on 23rd May 2018
Another portacath was inserted in to her body by surgical procedure on the 17th May 2018

Vinblastine is count dependent prior to treatment each week, as follows…
FBC (Full Blood Count) checked weekly 24 – 48 hours pre chemotherapy.
If Neutrophils more than 0.75 & platelets more than 100 – continue with 6mg/m2 dose.
If Neutrophils less than 0.75 but more than 0.5 & platelets less than 75 but more than 50 – give 4mg/m2 dose.
If Neutrophils less than 0.5 and / or platelets less than 50 – omit dose & delay until count recovery.

Week 01 – 23.05.18 – Vinblastine 4.7mg
Week 02 – 30.05.18 – Vinblastine 4.7mg
Week 03 – 06.06.18 – Vinblastine 4.7mg
Week 04 – 13.06.18 – Vinblastine 3.2mg (reduced dosage because neutrophil count of 0.7)
Week 05 – 20.06.18 – Vinblastine 0.0mg (skipped dosage because neutrophil count of 0.4)
Week 06 – 27.06.18 – Vinblastine 4.7mg
Week 07 – 04.07.18 – Vinblastine 4.7mg
Week 08 – 11.07.18 – Vinblastine 4.7mg
Week 09 – 18.07.18 – Vinblastine 0.0mg (skipped dosage because low platelet count of 27)
Week 10 – 25.07.18 – Vinblastine 4.7mg
Week 11 – 01.08.18 – Vinblastine 4.7mg
Week 12 – 08.08.18 – Vinblastine 4.7mg
Week 13 – 15.08.18 – Vinblastine 3.2mg (reduced dosage because neutrophil count of 0.6)

Dosages increased due to body weight/height recalculation…
Week 14 – 22.08.18 – Vinblastine 3.3mg (reduced dosage because neutrophil count of 0.6)
Week 15 – 29.08.18 – Vinblastine 4.9mg
Week 16 – 05.09.18 – Vinblastine 4.9mg
Week 17 – 12.09.18 – Vinblastine 4.9mg
Week 18 – 19.09.18 – Vinblastine 3.3mg (reduced dosage because neutrophil count of 0.5)
Week 19 – 26.09.18 – Vinblastine 3.3mg (reduced dosage because neutrophil count of 0.6)
Week 20 – 03.10.18 – Vinblastine 4.9mg
Week 21 – 10.10.18 – Vinblastine 3.3mg (reduced dosage because neutrophil count of 0.7)
Week 22 – 17.10.18 – Vinblastine 4.9mg
Week 23 – 24.10.18 – Vinblastine 4.9mg
Week 24 – 31.10.18 – Vinblastine 4.9mg
Week 25 – 07.11.18 – Vinblastine 3.3mg (reduced dosage because neutrophil count of 0.5)
Week 26 – 14.11.18 – Vinblastine 4.9mg