Abraxane (Nab Paclitaxel) as Radiation Sensitizer
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Transcript of Abraxane (Nab Paclitaxel) as Radiation Sensitizer
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Exploring the Role of Nab-paclitaxel (ABRAXANE®) as a
Radiation Sensitizer
Newer Dimensions in Radiation Therapy Presented at National Conference AROI Nov 2012
Dr. Lokesh Viswanath M.DProfessor, Dept of Radiation Oncology
Kidwai Memorial Institute of Oncology, Bangalore
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Radiation Sensitizer Agents possessing significant ability to augment the
effect of radiation– Super / sub-additive effect– Little or non-toxic at doses used– Minimal cytotoxic – Selective or preferential to tumor cf normal tissue– Counter act – determinants of radio-resistance > altering
the cancer cells radio-sensitivity– Cell survival curve – steeper slope (eliminate shoulder or
change the slope) • Shoulder – repair of radiation damage• Tail – resistance to CT agents
– Lesser systemic toxicity – Minimal or manageable enhancement of Radiation
toxicity
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Paclitaxel Approval - U.S FDA • Paclitaxel for treatment
– ovarian cancer : December 29, 1992– breast cancer : April 15, 1994.
• approved - semi-synthetic form Docetaxel in -1995 • January 7, 2005:
– Abraxane™, a trademark of American BioScience, Inc unique fast track approval for MBC
• Oct 2012 for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
• 2012, Paclitaxel poliglumex– Orphan drug status for Treatment of GBM
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Paclitaxel • a potent cytotoxic agent • mechanism of action – interferes with mitotic spindle function – block the cell in the G2/M phase of the cell cycle – ↑ apoptosis and tumor reoxygenation also may occur • binds to & stabilizes microtubules - loss of microtubule
dynamics > impair the mitotic spindle• preventing microtubule depolymerization
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Preclinical Models• Classic radiobiological concept: Cell Cycle dependent Radio-
sensitivity
• Radio-sensitizing effect of Paclitaxel is dependent on – Duration of exposure– Drug concentration
• Contribution of P53 to Paclitaxel dependent Cyto-toxicity – Mutant P53 is more sensitive to Paclitaxel
• Theoretically Paclitaxel and RT act as non cross resistant agent– RT is effective in wild type P53– Paclitaxel in mutant P53
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Taxanes• Paclitaxel (Px) Highly hydrophobic (water insoluble)
• To enable Parentral Administration– Solvent : • Paclitaxel : – Polyethylated Castor Oil (Cremphor EL)– Ethanol – as vehicle
• Docetaxel– Polysorbate 80 – Ethanol
– Toxicities: (direct – 80% )• Hypersensitivity reactions • Prolonged & irreversible pripheral neuropathy (demyelination
& Axonal degeneration)
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Polyethylated Castor Oil - Cremphor EL • Disadvantages of Cremphor EL – in conventional Paclitaxel
– Entrapp paclitaxel in cremophor micelles at clinically relevant concentrations : limit ing > Px bioavailability & antitumour activity
– inhibits Px binding with endothelial cell and albumin > inhibition of gp60-caveolar mediated transport
– Prevent distribution of Px outside the circulation & into tissue > ↓ tumour Px concentration and low volume distribution - ↑ exposure of Px to Bone marrow - ↑ Hematological toxicity
– Cremphor EL – inhibits P glycoprotein in Hematopoietic progenitor cells
– Inhibition of hepatic elimination– Axonal degeneration, demyelination, irreversible sensory neuropathy– leach plasticizers
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Cremophor paclitaxelCremophor paclitaxel : : Large Micelles Observed in Plasma Large Micelles Observed in Plasma
Control plasma Plasma + Taxol
LargeMicelle
Hamad and Moghimi, Expert Opin. Drug Deliv. (2008) 5(2):205-219
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Rat – peripheral nerve
• Control: Saline • Test: – Cremophor Treated– Several degenerated Axons
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Need for Innovation
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• potential quantum benefits of miniaturization – Richard Feynman 1959
• Manipulation of atoms, molecules, and materials to form structures on the scale of nanometres (billionths of a metre).
• Particles having sizes less than 0.1m (100nm)– 1st : <100nm– 2nd : <10nm
Nanoparticle Technology
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Abraxane® : ABI -007• Albumin bound Nano particle• To improve Drug delivery and PK– American BioScience, Inc., Santa Monica,
California. – BIOCON (India)
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• A novel – 130 nanometer particle – 1/10th - platelet, – 1/20th - smallest blood vessels – 1/40th - RBC)
• Protosphere™ technology : – convert insoluble drugs into soluble nanoparticles – Enhanced drug delivery
• 1st anticancer agent (Paclitaxel) – incorporate albumin technology
• Albumin – unique– A natural carrier of lipophylic molecules – Preferential drug delivery: Albumin receptor medicated drug
transport across endothelial cells (ABI- 007 4.5 fold ↑ in paclitaxel transport)
• Cremophor-free: ↓ Hypersensitivity & Nerve damage
- Half life of Abraxane is 27 hours for the dose of (260mg/m2)
Abraxane® : ABI -007
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Therapeutic efficacy & TI of ABI 007 (Abraxane)
Trans endothelial transport of albumin is mediated by gp60 (albondin) receptor and activation of caveolin 1•Endothelial binding ↑9.9 x •Endothelial Trans-cytosis ↑4.2x •↑ Endothelial binding ABI007 - ↑ anti-angiogenic activity•↑ anti-tumour activity - ↑ enhanced intratumoral delivery
•AbI007 PK - plasma Clearance & Volume distribution – 50% higher
• Tumor Inhibition Paclitaxel AUC at equal doses is 33% higher for ABI007
• > 50% higher dose administration is feasible
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SAPRC Expression
• SPARC – Tumour secreted glycoprotein – 43kDa– High binding affinity to albumin– Modulates cell & extracellular matrix interaction– Key regulator of Cell proliferation, survival & migration
• SPARC ^up-regulation in Cancer cells• SPARC – albumin interaction– Facilitate accumulation of albumin in Tumour– Increase intracellular Paclitaxel – ^ effectiveness of
nab Paclitaxel
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Abraxane
Solvent based Paclitaxel
0 hr
0 hr
24 hr
Abraxane Stablility : Abraxane Stablility : Microscopic assessment at 5 mg/mL, 40 Microscopic assessment at 5 mg/mL, 40 C:C:
Unstable: aggregate ↓ drug delivery
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Cremphor base Paclitaxel - as Radiation Sensitizer
• Review of literature• CRT experiences in the last 2 decades - what
have we learnt ?
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Ca Cervix – CR rates when RT is combine with various Radiation Sensitizers
• RT alone 71%• RT + CDDP 87%• RT + CDDP + Paclitaxel 90%• RT + Carbo + Docetaxel 97%
Taxanes are Good Radiation SensitizersTrade off : Taxnes - Acute G3Toxicities
• GI ~ 58%• Hemat ~ 40%• Poor Compliance ~ 20 % Discontinued
• Compliance with Abraxane – 96% (as scheduled)
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Ca Cervix RT + Paclitaxel (as Radiation Sensitizer)
Which Scheduling may be better with RTOnce in 3 weeks PXSchedule
Weekly Px Schedule
CR - rates (Complete Response Rate)
70% 88-91 %
Hematological toxicity Gr3
61% 11%
2ys DFS 82%
3yr DFS 82% 70%
2yr OS 93%
3yr OS 86.6% 65%
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what we have learnt so far ?
Abraxane (ABI 001) – in Metastatic Breast Cancer
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Abraxane: Phase – I Trial
• MTD: 300mg/m2
• 70% higher than convetional 175mg/m2
• No - severe Hypersensitivity reaction• No – premedication• Administration time: 30 min v/s 90 min
regular paclitaxel• Pharmacokinetics: max AUC time curve : dose
135 – 300 mg.m2
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Abraxane: Phase – II Trial
• Metastatic breast cancer• 300mg/m2
ORR TTPAll : 48% 26.6 weeksABI-007 as 1st Line : 64% 63.6 weeks
Findings suggested: Abraxane – may offer important advantages over standard paclitaxel
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Nab Paclitaxel ABI-007 Abraxane
• In vitro ABI-007 Cremphore Paclitaxel– LD 50 47mg/kg/d 13.4mg/kgd– MTD 30 13.4
• Every 3 wk – ABX – MTD 300mg/m2
• Response Rate 42% 27% (Equi Toxic Doses) 260mg/m2 175mg/m2
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Ca Breast : Safety profile of ABI007ABI007260mg/m2
CREMPHOR BASED PACLITAXEL175mg/m2
Tumour Response rates
33% 19% P 0.001
TT progression 23 wk 16.9 wk P 0.006
Gr 4 Neutropenia 9% 22% P 0.001
Sensory neuropathy 10% Temporary 2% P 0.001
250mg/m232% (Gr3) axona
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MBC – weekly nab Paclitaxel
median OS (mo)
• Weekly Nab Paclitaxel 150mg/m2 qw 3/4 - 33.8• Nab Paclitaxel 300mg/m2 q3w - 27.7• Docetaxel 100mg/m2 qw 3/4 - 26.6
Form H&N Ca TAX studies we know that Docetaxel is better that Paclitaxel
Weekly Abraxane Schedule is Equivalent to Docetaxel
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MTD - in Weekly schedule
Exploring What Doses of Abraxane needs to be used for Concurrent Chemoradiation
• Paclitaxel 50mg/m2/wk when combined with CDDP 30-60mg/m2
• Abraxane : 100mg/m2/wk In heavily pre- treated subjects
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Combination : is CDDP or Carbo Better ?ORR
CDDP + Paclitaxel 29% (Ca Cx recurrence)
Carbo + Paclitaxel 53% CDDP+5Fu+Abraxane 100% (H&N) CR -53%
Weekly CDDP v/s Weekly Carbo v/s once in 3 weeks schedule
• For Indian setting use of RT + Radiation Sensitizer - Weekly CDDP 40mg/m2 with Abraxane 75mg/m2 (50 -100) may be suitable , without enhanced RT toxicities
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• Giving a taxane with radiation at the present time is, however, investigational.
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Newer dimension's in Radiation sensitization – Abraxane ABI-007
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Radiation-modulating effects of ABRAXANE ABI 007
in tumor and normal tissues Pre Clinical Study: Mice - syngeneic ovarian or mammary Ca
• nab-paclitaxel produced supra-additive effects when given before radiation
• Nab-paclitaxel significantly increased radiocurability by reducing the dose yielding 50% tumor cure (TCD50) from 54.3 to 35.2 Gy.
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• ABI 007 is also being evaluated for the treatment of non-small cell lung cancer, ovarian cancer, melanoma and cervical cancers. Phase I/II trials have also been conducted in other solid tumours, including squamous cell cancer of the head and neck, and pelvis.
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Tisheret et al (2012), A Phase I/II Trial of Concurrent Abraxane in Combination With Carboplatin and Intensity Modulated Radiation Therapy (IMRT) in Locally Advanced Squamous Cancer of the Head and Neck
Rationale: favorable biodistrubition of Abraxane may allow loco-regional treatment without increasing normal tissue toxicity
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LASCCHN - Abraxane CRT
• Phase I – Dose escalation study• n=28• Median f/u 25 mo• Nab paclitaxel + Carbo + IMRT • Abraxane – 50mg/m2 • G3 Gysphagia, mucositis & dermaitiis – 85%• No DLT observed• Control rates ~ 82%
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L. A. Nedzi et al (2010). Phase I Study Of Nab-paclitaxel, Cisplatin And Cetuximab With Concurrent Radiation Therapy For Local-regionally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
• n=11• The maximum tolerated dose of weekly nab-paclitaxel given
concurrently with cisplatinum, cetuximab and 70 Gy continuous course radiotherapy for loco-regionally advanced HNSCC is 20mg/m2
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Phase I Trial of ABI-007 (Abraxane) Plus Cisplatin Plus 5-Fluorouracil (APF) as Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Squamous Cell Cancers of the Head and Neck (HNSCC)
– Drug: • ABI-007 Dose escalation beginning with ABI-007 75 mg/m2 day 1
+ day 8, • Cisplatin 100 mg/m2 day 1, • 5-FU 1000 mg/m2/d continuous infusion x 96 hours on day 1-4, • for 3 weeks x 3 cycles.• Followed by Concurrent weekly Carboplatin (AUC 1.5) with
radiotherapy for 7 weeks..
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H&N : Induction CT + CRT OS PFS 2YRS
TAX 232: Induction + RT alone PF ~35% 2YRS
TPF ~45%
TAX 324: Induction + CRT PF 55% 42% 2YRS
TPF 67% 54%
ACPF+CRT 84% 65% 2YRS
Abraxane: 100mg/m2/wkC225-250 Mg/m2/wkCDDP-75mgm2 x 3wk5FU-750m/m2 dy1-5 x 3wk
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Paclitaxel poliglumex
• 2012 FDA - Orphan drug status for Treatment of GBM
• Phase II : Paclitaxel P (50mg/m2) + TMZ + RT• N=25 (GBM-15), Median f/u 10.2 mo• CR-24%, PR-16%, SD-40%• PFS – 76%• GBM PFS – 66.7% (Stupp 53.9%)• AE: G3 Neutopenia – 4%, Thrombocytopenia -24%
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Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)– To establish recommended dose of weekly (Abraxane®)
given concurrently with weekly cetuximab + definitive radiation therapy (IMRT) for patients with HNSCC.
– Memorial Sloan-Kettering Cancer Center– Completion Date 08/01/2012
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Current Ongoing Trials - Other Disease Sites for Chemo-radiation with Abraxane
• Ca Pancreas – Stastically significant improved responses reported
• Ca Oesophagus• Gastric Ca • Unresectable Metastatic Ca Prostate:
Abraxane Plus Hormonal Therapy • human Grade III astrocytoma cell line
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Abraxane as Radiation sensitizer
Other proposed Schedules:•A minimum of 3 hr prior exposure – G2/M block – lasting 24 hrs•Use 1/3 the weekly dose, 3 times/week – maintains G2/M block
•ABRAXANE• 75 - 150 mg/m2 weekly IV over 30 min, x3 q4w
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Summary• Nab Paclitaxel Abraxane (ABI 007) – is one of the latest nanoparticle
molecule to be used as a Radiation sensitizer • The results of the recently completed clinical trials are eagerly awaited• Preliminary reports are encouraging • The response rates and toxicity profile of ABI 007 - potential use as
Radiation sensitizer in various Clinical setting in years to come• A Platin combination seems to be essential to achieve escalated
responses • Clinical Trials in Indian setting are being encouraged:
– we are in the process of designing Chemo-radiation schedule in various clinical settings
– The study design shall be relevant to our patients profile , radiation toxicity tolerances and supportive care available.
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Thank you