December 2010, Vol 3, No 8

Page 22

TON_December 2010_FINAL_TON 12/6/10 11:20 AM Page 20

Lung Cancer

Stereotactic Radiation May Be as Effective as Surgery for Some Non–small-cell Lung Cancers See also pages 25 & 32. By John Schieszer

SAN DIEGO—Stereotactic radiation appears to be highly effective and safe for treatment of patients with operable,

ALOXIÂŽ (palonosetron HCl) injection BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE Chemotherapy-Induced Nausea and Vomiting ALOXI is indicated for: L =23@/B3:G 3;3B=53<71 1/<13@ 163;=B63@/>G K >@3D3<B7=< =4 /1CB3 /<2 23:/G32 </CA3/ /<2 D=;7B7<5 /AA=17/B32 E7B6 7<7B7/: /<2 @3>3/B 1=C@A3A L 756:G 3;3B=53<71 1/<13@ 163;=B63@/>G K >@3D3<B7=< =4 /1CB3 </CA3/ /<2 D=;7B7<5 /AA=17/B32 E7B6 7<7B7/: /<2 @3>3/B 1=C@A3A DOSAGE AND ADMINISTRATION Recommended Dosing Chemotherapy-Induced Nausea and Vomiting =A/53 4=@ 2C:BA / A7<5:3 ;5 ) 2=A3 /2;7<7AB3@32 =D3@ A31=<2A =A7<5 A6=C:2 =11C@ />>@=F7;/B3:G ;7<CB3A 034=@3 B63 AB/@B =4 163;=B63@/>G Instructions for I.V. Administration "+ 7A AC>>:732 @3/2G 4=@ 7<B@/D3<=CA 7<831B7=< "+ A6=C:2 <=B 03 ;7F32 E7B6 =B63@ 2@C5A :CA6 B63 7<4CA7=< :7<3 E7B6 <=@;/: A/:7<3 034=@3 /<2 /4B3@ /2;7<7AB@/B7=< =4 "+ #/@3<B3@/: 2@C5 >@=2C1BA A6=C:2 03 7<A>31B32 D7AC/::G 4=@ >/@B71C:/B3 ;/BB3@ /<2 27A1=:=@/B7=< 034=@3 /2;7<7AB@/B7=< E63<3D3@ A=:CB7=< /<2 1=<B/7<3@ >3@;7B CONTRAINDICATIONS "+ 7A 1=<B@/7<271/B32 7< >/B73<BA 9<=E< B= 6/D3 6G>3@A3<A7B7D7BG B= B63 2@C5 =@ /<G =4 7BA 1=;>=<3<BA [see Adverse Reactions (6) 7< 4C:: >@3A1@707<5 7<4=@;/B7=< ] WARNINGS AND PRECAUTIONS Hypersensitivity G>3@A3<A7B7D7BG @3/1B7=<A ;/G =11C@ 7< >/B73<BA E6= 6/D3 3F6707B32 6G>3@A3<A7B7D7BG B= =B63@ '

@313>B=@ /<B/5=<7ABA ADVERSE REACTIONS 31/CA3 1:7<71/: B@7/:A /@3 1=<2C1B32 C<23@ E723:G D/@G7<5 1=<27B7=<A /2D3@A3 @3/1B7=< @/B3A =0A3@D32 7< B63 1:7<71/: B@7/:A =4 / 2@C5 1/<<=B 03 27@31B:G 1=;>/@32 B= @/B3A 7< B63 1:7<71/: B@7/:A =4 /<=B63@ 2@C5 /<2 ;/G <=B @3J 31B B63 @/B3A @3>=@B32 7< >@/1B713 < 1:7<71/: B@7/:A 4=@ B63 >@3D3<B7=< =4 </CA3/ /<2 D=;7B7<5 7<2C132 0G ;=23@/B3:G =@ 6756:G 3;3B=53<71 163;=B63@/>G

/2C:B >/B73<BA @3137D32 >/:=<=A3B@=< 2D3@A3 @3/1B7=<A E3@3 A7;7:/@ 7< 4@3?C3<1G /<2 A3D3@7BG E7B6 "+ /<2 =<2/<A3B@=< =@ 2=:/A3B@=< =::=E7<5 7A / :7AB7<5 =4 /:: /2D3@A3 @3/1B7=<A @3>=@B32 0G ≼ =4 >/B73<BA 7< B63A3 B@7/:A '/0:3 Table 1: Adverse Reactions from ChemotherapyInduced Nausea and Vomiting Studies ≼ 2% in any Treatment Group ALOXI Ondansetron Dolasetron Event 0.25 mg 32 mg I.V. 100 mg I.V. (N=410) (N=194) (N=633) 3/2/163

=<AB7>/B7=<

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< =B63@ ABC273A AC0831BA 3F>3@73<132 A3D3@3 1=<AB7>/B7=< 4=::=E7<5 / A7<5:3 >/:=<=A3B@=< 2=A3 =4 />>@=F7;/B3:G ;5 B6@33 B7;3A B63 @31=;;3<232 2=A3 "<3 >/B73<B @3137D32 / ;15 95 =@/: 2=A3 7< / >=AB=>3@/B7D3 </CA3/ /<2 D=;7B7<5 ABC2G /<2 =<3 63/:B6G AC0831B @3137D32 / ;5 ) 2=A3 7< / >6/@;/1=97<3B71 ABC2G < 1:7<71/: B@7/:A B63 4=::=E7<5 7<4@3?C3<B:G @3>=@B32 /2D3@A3 @3/1B7=<A /AA3AA32 0G 7<D3AB75/B=@A /A B@3/B;3<B @3:/B32 =@ 1/CA/:7BG C<9<=E< =11C@@32 4=::=E7<5 /2;7<7AB@/B7=< =4 "+ B= /2C:B >/B73<BA @3137D7<5 1=<1=;7B/<B 1/<13@ 163;=B63@/>G /@27=D/A1C:/@ <=< ACAB/7<32 B/16G1/@27/ 0@/2G1/@27/ 6G>=B3<A7=< 6G>3@B3<A7=< ;G=1/@27/: 7A163;7/ 3FB@/AGAB=:3A A7<CA B/16G1/@27/ A7<CA /@@6GB6;7/ AC>@/D3<B@71C:/@ 3FB@/AGAB=:3A /<2 $' >@=:=<5/B7=< < ;/<G 1/A3A B63 @3:/B7=<A67> B= "+ E/A C<1:3/@ 3@;/B=:=571/: /::3@571 23@;/B7B7A @/A6 3/@7<5 /<2 )7A7=< ;=B7=< A719<3AA B7<<7BCA 3G3 7@@7B/B7=< /<2 /;0:G=>7/ /AB@=7<B3AB7</: &GAB3; 27/@@63/ 2GA>3>A7/ /02=;7</: >/7< 2@G ;=CB6 6711C>A /<2 J /BC:3<13

20

December 2010 I VOL 3, NO 8

early-stage non–small-cell lung cancer (NSCLC). In some cases, it may be an appropriate alternative surgery, resulting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ostmarketing Experience '63 4=::=E7<5 /2D3@A3 @3/1B7=<A 6/D3 033< 723<B7I 32 2C@7<5 >=AB/>>@=D/: CA3 =4 "+ 31/CA3 B63A3 @3/1B7=<A /@3 @3>=@B32 D=:C<B/@7:G 4@=; / >=>C:/B7=< =4 C<13@B/7< A7H3 7B 7A <=B /:E/GA >=AA70:3 B= @3:7/0:G 3AB7;/B3 B637@ 4@3?C3<1G =@ 3AB/0:7A6 / 1/CA/: @3:/B7=<A67> B= 2@C5 3F>=AC@3 )3@G @/@3 1/A3A =4 6G>3@A3<A7B7D7BG @3/1B7=<A /<2 7<831B7=< A7B3 @3/1B7=<A 0C@<7<5 7<2C@/B7=< 27A1=;4=@B /<2 >/7< E3@3 @3>=@B32 4@=; >=AB;/@93B7<5 3F>3@73<13 =4 "+ ;5 7< B63 >@3D3<B7=< =4 163;=B63@/>G 7<2C132 </CA3/ /<2 D=;7B7<5 DRUG INTERACTIONS #/:=<=A3B@=< 7A 3:7;7</B32 4@=; B63 0=2G B6@=C56 0=B6 @3</: 3F1@3B7=< /<2 ;3B/0=:71 >/B6E/GA E7B6 B63 :/BB3@ ;327/B32 D7/ ;C:B7>:3 ,# 3<HG;3A C@B63@ 7< D7B@= ABC273A 7<271/B32 B6/B >/:=<=A3B@=< 7A <=B /< 7<6707B=@ =4 ,# ,# ,# ,# ,# ,# /<2 ,# ,# E/A <=B 7<D3AB75/B32 <=@ 2=3A 7B 7<2C13 B63 /1B7D7BG =4 ,# ,# =@ ,# '63@34=@3 B63 >=B3<B7/: 4=@ 1:7<71/::G A75<7I 1/<B 2@C5 7<B3@/1B7=<A E7B6 >/:=<=A3B@=< />>3/@A B= 03 :=E =/2;7<7AB@/B7=< =4 ;5 ) >/:=<=A3B@=< /<2 ;5 ) 23F/;3B6/A=<3 7< 63/:B6G AC0831BA @3D3/:32 <= >6/@;/1=97<3B71 2@C5 7<B3@/1B7=<A 03BE33< >/:=<=A3B@=< /<2 23F/;3B6/A=<3 < /< 7<B3@/1B7=< ABC2G 7< 63/:B6G AC0831BA E63@3 >/:=<=A3B@=< ;5 ) 0=:CA E/A /2;7<7AB3@32 =< 2/G /<2 =@/: />@3>7B/<B 4=@ 2/GA ;5 ;5 ;5 B63 >6/@;/1=97<3B71A =4 >/:=<=A3B@=< E3@3 <=B A75<7I 1/<B:G /:B3@32 ( <= 16/<53 ;/F 7<1@3/A3 ABC2G 7< 63/:B6G D=:C<B33@A 7<D=:D7<5 A7<5:3 2=A3 ) >/:=<=A3B@=< ;5 /<2 AB3/2G AB/B3 =@/: ;3B=1:=>@/;723 ;5 4=C@ B7;3A 2/7:G 23;=<AB@/B32 <= A75<7I 1/<B >6/@;/1=97<3B71 7<B3@/1B7=< < 1=<B@=::32 1:7<71/: B@7/:A "+ 7<831B7=< 6/A 033< A/43:G /2;7<7AB3@32 E7B6 1=@B71=AB3@=72A /</:53A71A /<B73;3B71A /<B7</CA3/<BA /<B7A>/A;=271A /<2 /<B716=:7<3@571 /53<BA #/:=<=A3B@=< 272 <=B 7<6707B B63 /<B7BC;=@ /1B7D7BG =4 B63 I D3 163;=B63@/>3CB71 /53<BA B3AB32 17A>:/B7< 1G1:=>6=A>6/;723 1GB/@/07<3 2=F=@C0717< /<2 ;7B=;G17< 7< ;C@7<3 BC;=@ ;=23:A USE IN SPECIFIC POPULATIONS Pregnancy '3@/B=53<71 4431BA /B35=@G '3@/B=:=5G ABC273A 6/D3 033< >3@4=@;32 7< @/BA /B =@/: 2=A3A C> B= ;5 95 2/G B7;3A B63 @31=;;3<232 6C;/< 7<B@/D3<=CA 2=A3 0/A32 =< 0=2G AC@4/13 /@3/ /<2 @/007BA /B =@/: 2=A3A C> B= ;5 95 2/G B7;3A B63 @31=;;3<232 6C;/< 7<B@/D3<=CA 2=A3 0/A32 =< 0=2G AC@4/13 /@3/ /<2 6/D3 @3D3/:32 <= 3D723<13 =4 7;>/7@32 43@B7:7BG =@ 6/@; B= B63 43BCA 2C3 B= >/:=<=A3B@=< '63@3 /@3 6=E3D3@ <= /23?C/B3 /<2 E3:: 1=<B@=::32 ABC273A 7< >@35</<B E=;3< 31/CA3 /<7;/: @3>@=2C1B7=< ABC273A /@3 <=B /:E/GA >@3271B7D3 =4 6C;/< @3A>=<A3 >/:=<=A3B@=< A6=C:2 03 CA32 2C@7<5 >@35</<1G =<:G 74 1:3/@:G <33232 Labor and Delivery #/:=<=A3B@=< 6/A <=B 033< /2;7<7AB3@32 B= >/B73<BA C<23@5=7<5 :/0=@ /<2 23:7D3@G A= 7BA 34431BA =< B63 ;=B63@ =@ 167:2 /@3 C<9<=E< Nursing Mothers B 7A <=B 9<=E< E63B63@ >/:=<=A3B@=< 7A 3F1@3B32 7< 6C;/< ;7:9 31/CA3 ;/<G 2@C5A /@3 3F1@3B32 7< 6C;/< ;7:9 /<2 031/CA3 =4 B63 >=B3<B7/: 4=@ A3@7=CA /2D3@A3 @3/1B7=<A 7< <C@A7<5 7<4/<BA /<2 B63 >=B3<B7/: 4=@ BC;=@753<717BG A6=E< 4=@ >/:=<=A3B@=< 7< B63 @/B 1/@17<=53<717BG ABC2G / 2317A7=< A6=C:2 03 ;/23 E63B63@ B= 27A1=<B7<C3 <C@A7<5 =@ B= 27A1=<B7<C3 B63 2@C5 B/97<5 7<B= /11=C<B B63 7;>=@B/<13 =4 B63 2@C5 B= B63 ;=B63@

in fewer side effects, according to a new Japanese study presented at the 52nd annual meeting of the American

Pediatric Use &/43BG /<2 34431B7D3<3AA 7< >/B73<BA 03:=E B63 /53 =4

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Society for Radiation Oncology. Stereotactic body radiation therapy (SBRT) is an increasingly popular treatment and has been shown to be effective in medically inoperable stage I NSCLC patients. This trial, however, was the first to examine its use in stage I lung cancer patients who are eligible for surgery. “We can now confirm with more confidence that SBRT is an effective treatment alternative for [older] aged patients with non–small-cell lung cancer,� said Yasushi Nagata, MD, a professor of radiation oncology at Hiroshima University, Japan. “In the future, there is a possibility that radiation will be a substitute for surgery in selected patients with stage I NSCLC. I encourage patients with early lung cancer to talk to their doctor to understand all their treatment options.� In this study, patients underwent four radiation treatments over the course of 4 to 8 days. SBRT, sometimes called radiosurgery, refers to a single or several highly targeted radiation treatments. From July 2004 to January 2007, 65 patients from 15 institutions were followed for a median of 45 months posttreatment. Researchers sought to determine the effectiveness and safety of stereotactic radiation treatments by determining the patient group’s overall survival at 3 years after treatment (76%). The mean age of the patients was 79 years (range, 50-91 years), and 45 of 65 patients were men. The median tumor size was 21 mm (range, 10-30 mm). To date, a total of 25 progressions have been observed, and the 3-year progression-free survival rate is 54.5%. The local progression-free survival rate at 3 years is 68.5%, and the event-free survival rate is 51.4%. No grade 4 or 5 toxicities have been observed. Grade 3 adverse events included chest pain in 1.5%, dyspnea in 3.1%, hypoxia in 1.5%, and pneumonitis in 3.1%. “This would be a lot less painful than surgery,� said Nagata in an interview with The Oncology Nurse. “There is also a big cost savings. The cost could be half of surgery. This is something that American cancer specialists may want to think about. It is important for the oncology nurse to know about this too. This could be a substitute for surgery, and patients need to know this.� He said this study is particularly important because it included so many older-aged patients. Nagata said that in the United States this approach for these patients is only now starting to become part of clinical practice. �

www.TheOncologyNurse.com


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