adjuvant therapy - dr. roda amaria
TRANSCRIPT
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Adjuvant and Neoadjuvant Therapy in Melanoma
R. Amaria, MD
Assistant Professor, Melanoma Medical Oncology
1/31/2015
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• Adjuvant therapy: additional cancer treatment given after surgery is complete to lower the risk of the cancer returning
• Neoadjuvant therapy: treatment given as a first step to shrink a tumor before surgery is performed
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Adjuvant Therapy for Stage III Disease
Surgery Adjuvant therapy
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Ideal Adjuvant Therapy
• Effective in destroying microscopic deposits of melanoma that could potentially be present after surgery
• Has limited or easily manageable toxicity
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FDA Approved Medical Adjuvant Therapy
• Interferon-α and Pegylated interferon
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Clinical Trials for Adjuvant Therapy
• Vaccines• New immunotherapies-ipilimumab, anti PD-1 antibodies
Patients with Surgically Removed Stage IIIa-IIIc melanoma
Ipilimumab10mg/kg
Placebo
Placebo Ipilimumab
Median time to relapse
17 months 26 months
Median overall survival
Not statistically different
Not statistically different
Significant toxicity rate
2% 49%
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Neoadjuvant Therapy for Stage III Disease and Limited Stage IV disease
Surgery Adjuvant therapyNeoadjuvant Therapy
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Ideal Neoadjuvant Therapy
• Effective in shrinking down tumor rapidly• Has easily manageable or predictable toxicity profile• Facilitates understanding of mechanisms of
response to therapy
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87yo man with stage IIIc BRAF Mutated Melanoma
November 2014 January 2015
BRAF/MEKInhibition
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November 2014January 2015
2 cycles of biochemotherapy
60 year old man with locally advanced sinonasal melanoma
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Patients with stage IIIB/IIIC or oligometastatic stage IV (<3 lesions), + BRAF mutation
Blood draw and tumor
biopsyPre-treatment
Neoadjuvant BRAF/MEK x 8
weeks
Blood draw and tumor
biopsyat surgery
Restaging CT scans every
3 months with blood draws
Arm AUpfront surgery
Arm BNeoadjuvantBRAFi/MEKI
Surgical resection
Restaging via CTs followed by
surgical resection
Scheduled within 0-4
weeks
On treatment biopsy / blood draw (arm B
only)
Adjuvant BRAF/MEK x
44 weeks
Standard of care adjuvant therapy
(interferon vs. observation)
Follow up
Neoadjuvant Therapy Clinical Trials
Follow up
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Patients with
stage IIIB/IIIC or
oligometastatic
stage IV
(≤3 lesions)
Blood draw
and tumor
biopsy
Pre-treatment
Blood draw
and tumor
harvested
at surgery
Restaging
CT scans
every 12
weeks
n=20
n=20
Arm ANeoadjuvant Nivolumab(4 doses)
Surgery
On treatment
biopsy /
blood draw
(prior to
dose 2 and
dose 3)
Adjuvant
Nivolumab x 6
months
Arm BNeoadjuvant Ipilimumab
& Nivolumab(3 doses)
Surgery
Adjuvant
Nivolumab x 6
months
Follow up
Follow up
Neoadjuvant Therapy Clinical Trials
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Adjuvant and Neoadjuvant Therapy Summary
• Adjuvant therapy is administered after surgery to lessen the risk of melanoma recurring– Interferon/Pegylated Interferon are FDA
approved options– Clinical trials are ongoing
• Neoadjuvant therapy is given to shrink tumor down before surgery– Multiple clinical trials are ongoing or planned
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Thank you for your attention
Questions?