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CLINICAL NEWS |
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immunomodulatory therapy ,” the authors concluded . “ This will allow patients to continue what may be beneficial therapy and the generation of data that can be analyzed to determine whether this strategy of treatment past IR does indeed confer a clinical benefit .”
“ Physicians need to be aware of this possibility when using drugs with the potential for a flare ,” Dr . Cheson told ASH Clinical News . “ If pseudoprogression is
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suspected , the patient should be left on the medication if he or she appears to be otherwise responding and there is no evidence of clinical deterioration until a repeat scan clarifies whether the observation was a flare or actual progression .”
The study is limited by the subjective nature of certain measures included in the IR definition , such as “ clinical deterioration .”
In an editorial accompanying the report , Joseph M . Connors , MD , from the
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British Columbia Cancer Agency Centre for Lymphoid Cancers in Canada , discussed the challenges of implementing these new LYRIC criteria . “ What will be particularly challenging is the necessity to avoid the mistake of considering a new agent ineffective , while at the same time protecting patients from continuing to be exposed to worsening toxicity because off-target tissue injury is erroneously considered non-specific . |
It is imperative that we remember the provisional nature of these proposed changes and actively participate in their refinement .” 2
REFERENCES
1 . Cheson BD , Ansell S , Schwartz L , et al . Refinement of the Lugano classification response criteria for lymphoma in the era of immunomodulatory therapy : The LYmphoma response to immunomodulatory therapy criteria ( LYRIC ). Blood . 2016 August 29 . [ Epub ahead of print ]
2 . Connors JM . Is the lymphoma better ? Not easy to determine . Blood . 2016 ; 128:2481-82 .
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The first and only oral proteasome inhibitor
• The approval of the NINLARO ® ( ixazomib ) regimen ( NINLARO + lenalidomide + dexamethasone ) was based on a statistically significant ~ 6 month improvement in median progression-free survival vs the placebo regimen ( placebo + lenalidomide + dexamethasone ) — Median PFS : 20.6 vs 14.7 months ( 95 % CI , 17.0-NE and 95 % CI , 12.9-17.6 , respectively )
- HR = 0.74 ( 95 % CI , 0.587-0.939 ); P = 0.012
steatosis , hepatitis cholestatic and hepatotoxicity have each been reported in < 1 % of patients treated with NINLARO . Events of liver impairment have been reported ( 6 % in the NINLARO regimen and 5 % in the placebo regimen ). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed .
• Embryo-fetal Toxicity : NINLARO can cause fetal harm . Women should be advised of the potential risk to a fetus , to avoid becoming pregnant , and to use contraception during treatment and for an additional 90 days after the final dose of NINLARO .
ADVERSE REACTIONS The most common adverse reactions ( ≥ 20 %) in the NINLARO regimen and greater than the placebo regimen , respectively , were diarrhea ( 42 %, 36 %), constipation ( 34 %, 25 %), thrombocytopenia ( 78 %, 54 %; pooled from adverse events and laboratory data ), peripheral neuropathy ( 28 %, 21 %), nausea ( 26 %, 21 %), peripheral edema ( 25 %, 18 %), vomiting ( 22 %, 11 %), and back pain ( 21 %, 16 %). Serious adverse reactions reported in ≥ 2 % of patients included thrombocytopenia ( 2 %) and diarrhea ( 2 %).
SPECIAL POPULATIONS
• Hepatic Impairment : Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment .
• Renal Impairment : Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis . NINLARO is not dialyzable .
• Lactation : Advise women to discontinue nursing while on NINLARO .
DRUG INTERACTIONS : Avoid concomitant administration of NINLARO with strong CYP3A inducers .
TOURMALINE-MM1 : a global , phase 3 , randomized ( 1:1 ), double-blind , placebo-controlled study that evaluated the safety and efficacy of NINLARO ( an oral PI ) vs placebo , both in combination with lenalidomide and dexamethasone , until disease progression or unacceptable toxicity in 722 patients with relapsed and / or refractory MM who received at least 1 prior therapy .
MM = multiple myeloma ; NE = not evaluable ; PFS = progression-free survival ; PI = proteasome inhibitor .
Please see adjacent Brief Summary .
USO / IXA / 16 / 0100
ixazomib as a category 1 treatment option for previously treated multiple myeloma . 1