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Ahmed Zeeneldin
Anatomy




      Ahmed Zeeneldin   2
Incidence
— Worldwide:
  — Third incidence (~500, 000 anually)
  — Second cause of cancer death (~ 275, 000)
  — 75% of cases occur in developing countries




  — Why incidence is low in developed countries?
    —   Screening




                    Ahmed Zeeneldin                3
NCI-Egypt




       Ahmed Zeeneldin   4
Risk factors
— HPV: most important
  — High incidence areas: HPV 10-20%
  — Low incidence areas: HPV 5-10%
  — Immunization:
     —   Gardasil FDA approved in 2006
     —   Cervarix
— Other:
  — Smoking, parity, contraceptive use,
  — Early coitus, many sexual partners, history of STDs
  — chronic immunosuppression
                  Ahmed Zeeneldin                         5
HPV and cervical cancer




        Ahmed Zeeneldin   6
Vaccination Against HPV
—   Gardasil and Cervarix (C>G)
—   Protein of HPV 6, 11, 16, 18 (G) 16, 18 (C)
—   3 IM injections over 6 Months (G 0,2,6), (C 0,1,6)
—   Age
     —   most effective if given before sexual intercourse is initiated
     —   Girls and women ages 9 -26 years
     —   Not recommended for older than 26 years.
     —   Best for 11-12 years
— Effectiveness after 3 years (no CIN):
   — No prior HPV infection: 99%
   — Prior HPV infection: 44%
— Why to continue screening?
   — Not all HPV strains
   — Not 100% effective

— Males:
   — Penile cancer and anal cancer




                         Ahmed Zeeneldin                                  7
Screening
— Age:
   — 3 years after onset of vaginal intercourse
   — No later than 21 years
   — Till 70 y
— Methods:
   — Cytology:
     —   conventional smears annually
     —   liquid based every 2 y
   — HPV DNA testing: for age >30 y
     — Every 3 y in combination with cytology if –ve
     — If +ve at the discretion of the physician


— HPV vaccination: screened as usual, why?

                   Ahmed Zeeneldin                     8
Cytology needed
— Uterine cervix is accessible to physician
— Histology is needed
   1. Cervical cytology or
   2. Papanicolaou (Pap) smears or
   3. Cervical biopsy
   4. Cone biopsy: if others are inadequate or if degree of
       invasion needed.




                Ahmed Zeeneldin                               9
Cervical (pap) smear




        Ahmed Zeeneldin   10
Cone biopsy




       Ahmed Zeeneldin   11
CT




 Parametrial extension
                                   Pelvic wall extension   Bladder and rectum
 and uerter encasement
                                                           invasion



                 Ahmed Zeeneldin                                           12
Ahmed Zeeneldin   13
Ahmed Zeeneldin   14
Figure 2. Clinical and imaging stage IIIB cervical cancer in a 37-year-old woman with
                                        hydronephrosis at diagnosis




                          Pannu H K et al. Radiographics 2001;21:1155-1168



©2001 by Radiological Society of North America
Figure 4. Tumor extension into the vagina in a 50-year-old woman with clinical stage IIIB and
                                 imaging stage IIIA cervical cancer




                           Pannu H K et al. Radiographics 2001;21:1155-1168



©2001 by Radiological Society of North America
Histology
— Normal epithelial lining of cervix

— Cancer:
   — Squamous cell carcinoma (80%)
   — Adenosquamous
   — Adenocarcinoma
   — Others :
    —   Neuroendocrine carcinoma,
    —   small cell tumors,
    —   glassy-cell carcinomas,
    —   sarcomas,
                 Ahmed Zeeneldin       17
Clinical picture
— Asymptomatic
— Watery vaginal discharge
— Postcoital bleeding or
— Intermittent spotting.




               Ahmed Zeeneldin   18
Workup
— History and physical examination
— Routine lab:
   — CBCD, liver and renal function tests.
— Radiologic imaging :
   — Chest x-ray, CT, MRI, or PET;
— Cystoscopy and proctoscopy examination under
 anesthesia




              Ahmed Zeeneldin                    19
Staging of cervical CA
     T1=FI           (T2=FII)                    (T3=FIII)             (T4=FIVA)         N1         M1=FIVB

Confined to uterus   Outside uterus but not T3   Outside uterus to     Outside uterus to: Regional Distant spread
A: Microscopic       A: Parametrium negative     A: Vagina lower 1/3   A: Bladder or      LN       Including
   A1: 7H x 3D mm          A1: <= 4 cm           B: Pelvic wall,       rectal mucosa               peritoneal
   A2: 7H x 5D mm          A2: > 4 cm            Causing HN of NFK     B: Extrapelvic
B: Macroscopic       B: Parametrium positive                           extension
   B1: <= 4 cm
   B2: > 4 cm

                                                                                  No stage grouping
                                                                                  F =FIGO stage
                                                                                  HN:hydronenphrosis
                                                                                  NFK: non-functioning
                                                                                  kidney
                                                                                  M1=FIVB




                              Ahmed Zeeneldin                                                               20
Treatment modalities
— Surgery:
   — Limited: radical trachelectomy for tumors up to 2 cm if
     fertility preservation is desired
   — Extensive: radical hystrectomy +/- pelvic +/- PA LND
— Concomitant chemo-radiotherapy; CCRT: (Cisplatin)
— Palliative chemotherapy: cisplatin-based
— BSC




                Ahmed Zeeneldin                                21
Treatment of Cx CA
Stage                 stage                        Surg          CCRT         Chemo
Localized    micro    IA1       Micro 7Hx3D        Yes*          No           No

             micro    IA2       Micro 7H x 5D      Yes* ORà      RT alone**   No
             <=4cm    IB1              <=4cm    Yes * ORà        RT alone**   No
                      IIA1      Parmet -/ <=4cm
             >4cm     IB2                >4cm      Yes ORà       CCRT***      No
                      IIA2      Parmet -/ >4cm
Locally               IIB       Paramet +          No            CCRT         No
advanced              IIIA/B    LVag/Pel W
                      IVA       Blad/Rect/HN
Metastatic            IVB       Mets               No            No           Pall’tve
  * Surgery can be extensive or limited for fertility preservation
  *Post op CCRT can be given in : LN+, SM+, Parametrium +
  ** No surgery after CCRT
  *** adjuvant surg can be done after CCRT
                       Ahmed Zeeneldin                                              22
Surgery and CCRT
— If surgery was used first:
   — Post op CCRT can be given to high risk patients:
    —   positive lymph nodes, or
    —   parametrial extension, or
    —   positive margins)
— If CCRT was used first: surgery is not recommended




                  Ahmed Zeeneldin                       23
RT and surgery are equal in
Treatment of stage IB and IIA
                                 RT              Surgery
   IB & IIA                      171               172
                                       *(PO RT to => pIIB ~ 100 pt)
   5-y DFS                      74%                74%
   5-y OS                       83%                83%
   Recurrence                   26%                25%
   Severe morbidity*            19%                28%

— Landoni Eet al, Lancet. 1997 Aug 23;350(9077):535-40.




                    Ahmed Zeeneldin                                   24
Concurrent CRT
— CCRT
   — Improves DFS and OS compared to RT alone or RT+HU
— Cisplatin : standard
   — 40 mg/sm weekly up to 6 weeks (Max 70 mg)
   — Less toxic than 5FU/Cisplatin
— Cisplatin and 5FU: more toxic
   — 3 cycles:
     —   (1st and 2nd )D1-5, D22-26: during EBRT
     —   (3rd ) D1-5 during second brachytherapy course
   — Cisplatin 20 mg/sm/d x 5 d, FU 1000 mg/sm/d x 5d
— 5FU alone is not optimal
— Intolerance to ciaplatin: àcarboplatin or xeloda
   — Cb: 100mg/m or UC 2 weekly
— Novel regimen: weekly x 6 CCRT à adjuvant gem cis
   — CCRT: Cisplatin 40 mg/sm followed by Gem 125 mg/m2
   — Adj: Gem (1,000 mg/m2 on Days 1 and 8) plus Cis (50 mg/m2 on
     Day 1) x 2 cycles q 21 d

                     Ahmed Zeeneldin                                25
Adding Gemcitabine to cisplatin in
CRT
— Dueñas-González et al, 2011, JCO
— Patients and Methods Eligible chemotherapy- and
  radiotherapy-naive patients with stage IIB to IVA disease
  and Karnofsky performance score ≥ 70 were randomly
  assigned to:
— arm A (cisplatin 40 mg/m2 and gemcitabine 125 mg/m2
  weekly for 6 weeks with concurrent external-beam
  radiotherapy [XRT] 50.4 Gy in 28 fractions, followed by
  brachytherapy [BCT] 30 to 35 Gy in 96 hours, and then two
  adjuvant 21-day cycles of cisplatin, 50 mg/m2 on day 1, plus
  gemcitabine, 1,000 mg/m2 on days 1 and 8) :
— or to arm B (cisplatin and concurrent XRT followed by BCT
  only; dosing same as for arm A)

                Ahmed Zeeneldin                                  26
— Results Between May 2002 and March 2004, 515 patients
    were enrolled (arm A, n = 259; arm B, n = 256).
—   PFS at 3 years was significantly improved in arm A versus
    arm B (74.4% v 65.0%, respectively; P = .029),
—   as were overall PFS (log-rank P = .0227; hazard ratio [HR],
    0.68; 95% CI, 0.49 to 0.95),
—   overall survival (log-rank P = .0224; HR, 0.68; 95% CI, 0.49
    to 0.95),
—   and time to progressive disease (log-rank P = .0012; HR,
    0.54; 95% CI, 0.37 to 0.79).
—   Grade 3 and 4 toxicities were more frequent in arm A than
    in arm B (86.5% v 46.3%, respectively; P < .001), including
    two deaths possibly related to treatment toxicity in arm A.
                  Ahmed Zeeneldin                                  27
CCRT is better than RT alone in
Stage IB2-IVA




          Ahmed Zeeneldin         28
CCRT is better than RT alone in
Bulky stage IB2 and IIA (=> 5cm) & IIB-IVA
                                     RT                    CCRT
                                     193                   193

    5-y DFS                         40%               67% (P<0.001)
    5-y OS                          58%               73% (P<0.004)
    Recurrences and mets           higher
    Hem toxicity                                  Higher but reversibel

— Moris et al N Engl J Med. 1999 Apr 15;340(15):1137-43.
— Conclusions: CCRT > RT
— Cisplatin 20 mg/sm/d &FU 1000 mg/sm/d [x 5d x 3 courses]



                        Ahmed Zeeneldin                                   29
CCRT is better than RT alone in
Bulky stage IB and IIA (=> 4cm)
                             RT+Surgery         CRT+Surgery
                                   186               183

  RR of progression                     1       0.51 (P<0.001)
  RR of death                           1      0.54 (P=0.008)
  G3-4 Hem Toxicity                2%                21%
  GI toxicity                      5%                14%


— Keys HM et al, N Engl J Med. 1999 Apr 15;340(15):1154-61.
— Conclusions: CCRT > RT
— Cisplatin 40 mg/sm q w x 6 max 70 mg


                      Ahmed Zeeneldin                            30
CCRT with cisplatin is standard in
Bulky stage IIB-IVA
                                        RT+ cisplatin        RT+ cis+5FU+HU RT+HU
    SCC, adeno,                                 `175               `175         ~175
    AdenoSquamous
    PFS                               Higher (P<0.001)       higher (P<0.001)   Lower
    OS                                   Higher (P=s)         Higher (p=s)      lower
    RR of progression                           0.57               0.55           1
    RR of death                                 0.61              0.58            1

—   Rose et al, N Engl J Med. 1999 Apr 15;340(15):1144-53.
— Conclusions: CCRT > RT, Cis = cis/5FU > HU
— Cis 40 mg/sm/w x 6
— Cisplatin 50mg/sm d1 &FU 1000 mg/sm/d [x 4d x 2 courses]

                               Ahmed Zeeneldin                                          31
Chemotherapy for Rec/mets
— First-line combination therapy
   — Cisplatin/paclitaxel
   — Carboplatin/paclitaxel
   — Cisplatin/topotecan
   — Cisplatin/gemcitabine (category 2B)
— Possible first-line single agent therapy
   — Cisplatin (preferred as a single agent)
   — Carboplatin
   — Paclitaxel


              Ahmed Zeeneldin                  32
Chemotherapy for Rec/mets
— Second-line therapy††
   — Bevacizumab
   — Docetaxel
   — 5-FU (5-fluorouracil)
   — Gemcitabine
   — Ifosfamide
   — Irinotecan
   — Topotecan
   — Pemetrexed (category 3)
   — Vinorelbine (category 3


               Ahmed Zeeneldin   33
Treatment of metastatic disease
— Systemic chemotherapy and
— Individualized radiotherapy.




              Ahmed Zeeneldin     34
Relapse
— Locoregional
— Systemic




             Ahmed Zeeneldin   35
Relapse
— Locoregional therapy
   — After surgery: CCRT
   — After RT: possible surgery
   — After surgery and CCRT: platinum-based CT/BSC
— Systemic therapy
   — Extrapelvic or para-aortic recurrence(s) at multiple sites
     or with unresectable recurrence
     —   Platinum-based CT/BSC
   — Surgery has limited role for isolated sites


                  Ahmed Zeeneldin                                 36
Palliative chemotherapy
— Recurrent or metastatic disease
— Not candidate for surgery or RT
— Platinum-based (most active, RR 20-30%)
— Compared with cisplatin:
   — Combinations :
   — Same QOL, little or no OS advantage
    —   cisplatin/paclitaxel and
    —   cisplatin/topotecan (category 1 for both)



                  Ahmed Zeeneldin                   37
Cisplatin-paclitaxel
                              cispaltin   Cisplatin - pacliatxel
   IVB recurrent or               134              130
   persistent SCC
   RR (CR)                     19 (6)%          36 (15)%
   Median PFS                   2.8 m        4.8 m (P < .001)
   Median OS                    8.8 m          9.7 m (PNS)
   QOL                          same              same
   Anemia/neutropenia                             more

— Moore et al, J Clin Oncol 2004;22:3113-3119



                      Ahmed Zeeneldin                              38
Cisplatin- topotecan
                                Cispaltin       Cisplatin - topotecan
                                    146                    147
     RR                             13%                   27%
     Median PFS                    2.9 m            4.6 m (P=0.014)
     Median OS                     6.5 m            9.4 m (P=0.017)
     QOL                           same                  same
     Anemia/neutropenia                                  more

 —   Long HJ et al, J Clin Oncol. 2005 Jul 20;23(21):4626-33.
 —   Cis 50 mg/sm q 3w
 —   Topo 0.75 mg/sm/d x 3 d q 3w
 —   MVAC third arm was closed due to high mortality
 —   Fisrt to show OS advantage


                       Ahmed Zeeneldin                                  39
— PATIENTS AND METHODS:
— RCT of 3 regimens every 3 weeks doses in mg/m2
— paclitaxel 135 over 24 hours plus Cis 50 day 2 (PC);
— vinorelbine 30 days 1 &8     plus Cis 50 day 1 (VC);
— gemcitabine 1,000 day 1 &8 plus Cis 50 day 1 (GC);
— topotecan 0.75 days 1, 2, &3 plus Cis 50 day 1 (TC).


               Ahmed Zeeneldin                           40
Ahmed Zeeneldin   41
Ahmed Zeeneldin   42
Conclusions
•VC, GC, and TC are not superior to PC in terms of overall survival (OS).
•However, the trend in RR, PFS, and OS favors PC.
•Differences in chemotherapy scheduling, pre-existing morbidity, and toxicity are
important in individualizing therapy.


                     Ahmed Zeeneldin                                            43

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Cervical cancer 10 2011

  • 2. Anatomy Ahmed Zeeneldin 2
  • 3. Incidence — Worldwide: — Third incidence (~500, 000 anually) — Second cause of cancer death (~ 275, 000) — 75% of cases occur in developing countries — Why incidence is low in developed countries? — Screening Ahmed Zeeneldin 3
  • 4. NCI-Egypt Ahmed Zeeneldin 4
  • 5. Risk factors — HPV: most important — High incidence areas: HPV 10-20% — Low incidence areas: HPV 5-10% — Immunization: — Gardasil FDA approved in 2006 — Cervarix — Other: — Smoking, parity, contraceptive use, — Early coitus, many sexual partners, history of STDs — chronic immunosuppression Ahmed Zeeneldin 5
  • 6. HPV and cervical cancer Ahmed Zeeneldin 6
  • 7. Vaccination Against HPV — Gardasil and Cervarix (C>G) — Protein of HPV 6, 11, 16, 18 (G) 16, 18 (C) — 3 IM injections over 6 Months (G 0,2,6), (C 0,1,6) — Age — most effective if given before sexual intercourse is initiated — Girls and women ages 9 -26 years — Not recommended for older than 26 years. — Best for 11-12 years — Effectiveness after 3 years (no CIN): — No prior HPV infection: 99% — Prior HPV infection: 44% — Why to continue screening? — Not all HPV strains — Not 100% effective — Males: — Penile cancer and anal cancer Ahmed Zeeneldin 7
  • 8. Screening — Age: — 3 years after onset of vaginal intercourse — No later than 21 years — Till 70 y — Methods: — Cytology: — conventional smears annually — liquid based every 2 y — HPV DNA testing: for age >30 y — Every 3 y in combination with cytology if –ve — If +ve at the discretion of the physician — HPV vaccination: screened as usual, why? Ahmed Zeeneldin 8
  • 9. Cytology needed — Uterine cervix is accessible to physician — Histology is needed 1. Cervical cytology or 2. Papanicolaou (Pap) smears or 3. Cervical biopsy 4. Cone biopsy: if others are inadequate or if degree of invasion needed. Ahmed Zeeneldin 9
  • 10. Cervical (pap) smear Ahmed Zeeneldin 10
  • 11. Cone biopsy Ahmed Zeeneldin 11
  • 12. CT Parametrial extension Pelvic wall extension Bladder and rectum and uerter encasement invasion Ahmed Zeeneldin 12
  • 15. Figure 2. Clinical and imaging stage IIIB cervical cancer in a 37-year-old woman with hydronephrosis at diagnosis Pannu H K et al. Radiographics 2001;21:1155-1168 ©2001 by Radiological Society of North America
  • 16. Figure 4. Tumor extension into the vagina in a 50-year-old woman with clinical stage IIIB and imaging stage IIIA cervical cancer Pannu H K et al. Radiographics 2001;21:1155-1168 ©2001 by Radiological Society of North America
  • 17. Histology — Normal epithelial lining of cervix — Cancer: — Squamous cell carcinoma (80%) — Adenosquamous — Adenocarcinoma — Others : — Neuroendocrine carcinoma, — small cell tumors, — glassy-cell carcinomas, — sarcomas, Ahmed Zeeneldin 17
  • 18. Clinical picture — Asymptomatic — Watery vaginal discharge — Postcoital bleeding or — Intermittent spotting. Ahmed Zeeneldin 18
  • 19. Workup — History and physical examination — Routine lab: — CBCD, liver and renal function tests. — Radiologic imaging : — Chest x-ray, CT, MRI, or PET; — Cystoscopy and proctoscopy examination under anesthesia Ahmed Zeeneldin 19
  • 20. Staging of cervical CA T1=FI (T2=FII) (T3=FIII) (T4=FIVA) N1 M1=FIVB Confined to uterus Outside uterus but not T3 Outside uterus to Outside uterus to: Regional Distant spread A: Microscopic A: Parametrium negative A: Vagina lower 1/3 A: Bladder or LN Including A1: 7H x 3D mm A1: <= 4 cm B: Pelvic wall, rectal mucosa peritoneal A2: 7H x 5D mm A2: > 4 cm Causing HN of NFK B: Extrapelvic B: Macroscopic B: Parametrium positive extension B1: <= 4 cm B2: > 4 cm No stage grouping F =FIGO stage HN:hydronenphrosis NFK: non-functioning kidney M1=FIVB Ahmed Zeeneldin 20
  • 21. Treatment modalities — Surgery: — Limited: radical trachelectomy for tumors up to 2 cm if fertility preservation is desired — Extensive: radical hystrectomy +/- pelvic +/- PA LND — Concomitant chemo-radiotherapy; CCRT: (Cisplatin) — Palliative chemotherapy: cisplatin-based — BSC Ahmed Zeeneldin 21
  • 22. Treatment of Cx CA Stage stage Surg CCRT Chemo Localized micro IA1 Micro 7Hx3D Yes* No No micro IA2 Micro 7H x 5D Yes* ORà RT alone** No <=4cm IB1 <=4cm Yes * ORà RT alone** No IIA1 Parmet -/ <=4cm >4cm IB2 >4cm Yes ORà CCRT*** No IIA2 Parmet -/ >4cm Locally IIB Paramet + No CCRT No advanced IIIA/B LVag/Pel W IVA Blad/Rect/HN Metastatic IVB Mets No No Pall’tve * Surgery can be extensive or limited for fertility preservation *Post op CCRT can be given in : LN+, SM+, Parametrium + ** No surgery after CCRT *** adjuvant surg can be done after CCRT Ahmed Zeeneldin 22
  • 23. Surgery and CCRT — If surgery was used first: — Post op CCRT can be given to high risk patients: — positive lymph nodes, or — parametrial extension, or — positive margins) — If CCRT was used first: surgery is not recommended Ahmed Zeeneldin 23
  • 24. RT and surgery are equal in Treatment of stage IB and IIA RT Surgery IB & IIA 171 172 *(PO RT to => pIIB ~ 100 pt) 5-y DFS 74% 74% 5-y OS 83% 83% Recurrence 26% 25% Severe morbidity* 19% 28% — Landoni Eet al, Lancet. 1997 Aug 23;350(9077):535-40. Ahmed Zeeneldin 24
  • 25. Concurrent CRT — CCRT — Improves DFS and OS compared to RT alone or RT+HU — Cisplatin : standard — 40 mg/sm weekly up to 6 weeks (Max 70 mg) — Less toxic than 5FU/Cisplatin — Cisplatin and 5FU: more toxic — 3 cycles: — (1st and 2nd )D1-5, D22-26: during EBRT — (3rd ) D1-5 during second brachytherapy course — Cisplatin 20 mg/sm/d x 5 d, FU 1000 mg/sm/d x 5d — 5FU alone is not optimal — Intolerance to ciaplatin: àcarboplatin or xeloda — Cb: 100mg/m or UC 2 weekly — Novel regimen: weekly x 6 CCRT à adjuvant gem cis — CCRT: Cisplatin 40 mg/sm followed by Gem 125 mg/m2 — Adj: Gem (1,000 mg/m2 on Days 1 and 8) plus Cis (50 mg/m2 on Day 1) x 2 cycles q 21 d Ahmed Zeeneldin 25
  • 26. Adding Gemcitabine to cisplatin in CRT — Dueñas-González et al, 2011, JCO — Patients and Methods Eligible chemotherapy- and radiotherapy-naive patients with stage IIB to IVA disease and Karnofsky performance score ≥ 70 were randomly assigned to: — arm A (cisplatin 40 mg/m2 and gemcitabine 125 mg/m2 weekly for 6 weeks with concurrent external-beam radiotherapy [XRT] 50.4 Gy in 28 fractions, followed by brachytherapy [BCT] 30 to 35 Gy in 96 hours, and then two adjuvant 21-day cycles of cisplatin, 50 mg/m2 on day 1, plus gemcitabine, 1,000 mg/m2 on days 1 and 8) : — or to arm B (cisplatin and concurrent XRT followed by BCT only; dosing same as for arm A) Ahmed Zeeneldin 26
  • 27. — Results Between May 2002 and March 2004, 515 patients were enrolled (arm A, n = 259; arm B, n = 256). — PFS at 3 years was significantly improved in arm A versus arm B (74.4% v 65.0%, respectively; P = .029), — as were overall PFS (log-rank P = .0227; hazard ratio [HR], 0.68; 95% CI, 0.49 to 0.95), — overall survival (log-rank P = .0224; HR, 0.68; 95% CI, 0.49 to 0.95), — and time to progressive disease (log-rank P = .0012; HR, 0.54; 95% CI, 0.37 to 0.79). — Grade 3 and 4 toxicities were more frequent in arm A than in arm B (86.5% v 46.3%, respectively; P < .001), including two deaths possibly related to treatment toxicity in arm A. Ahmed Zeeneldin 27
  • 28. CCRT is better than RT alone in Stage IB2-IVA Ahmed Zeeneldin 28
  • 29. CCRT is better than RT alone in Bulky stage IB2 and IIA (=> 5cm) & IIB-IVA RT CCRT 193 193 5-y DFS 40% 67% (P<0.001) 5-y OS 58% 73% (P<0.004) Recurrences and mets higher Hem toxicity Higher but reversibel — Moris et al N Engl J Med. 1999 Apr 15;340(15):1137-43. — Conclusions: CCRT > RT — Cisplatin 20 mg/sm/d &FU 1000 mg/sm/d [x 5d x 3 courses] Ahmed Zeeneldin 29
  • 30. CCRT is better than RT alone in Bulky stage IB and IIA (=> 4cm) RT+Surgery CRT+Surgery 186 183 RR of progression 1 0.51 (P<0.001) RR of death 1 0.54 (P=0.008) G3-4 Hem Toxicity 2% 21% GI toxicity 5% 14% — Keys HM et al, N Engl J Med. 1999 Apr 15;340(15):1154-61. — Conclusions: CCRT > RT — Cisplatin 40 mg/sm q w x 6 max 70 mg Ahmed Zeeneldin 30
  • 31. CCRT with cisplatin is standard in Bulky stage IIB-IVA RT+ cisplatin RT+ cis+5FU+HU RT+HU SCC, adeno, `175 `175 ~175 AdenoSquamous PFS Higher (P<0.001) higher (P<0.001) Lower OS Higher (P=s) Higher (p=s) lower RR of progression 0.57 0.55 1 RR of death 0.61 0.58 1 — Rose et al, N Engl J Med. 1999 Apr 15;340(15):1144-53. — Conclusions: CCRT > RT, Cis = cis/5FU > HU — Cis 40 mg/sm/w x 6 — Cisplatin 50mg/sm d1 &FU 1000 mg/sm/d [x 4d x 2 courses] Ahmed Zeeneldin 31
  • 32. Chemotherapy for Rec/mets — First-line combination therapy — Cisplatin/paclitaxel — Carboplatin/paclitaxel — Cisplatin/topotecan — Cisplatin/gemcitabine (category 2B) — Possible first-line single agent therapy — Cisplatin (preferred as a single agent) — Carboplatin — Paclitaxel Ahmed Zeeneldin 32
  • 33. Chemotherapy for Rec/mets — Second-line therapy†† — Bevacizumab — Docetaxel — 5-FU (5-fluorouracil) — Gemcitabine — Ifosfamide — Irinotecan — Topotecan — Pemetrexed (category 3) — Vinorelbine (category 3 Ahmed Zeeneldin 33
  • 34. Treatment of metastatic disease — Systemic chemotherapy and — Individualized radiotherapy. Ahmed Zeeneldin 34
  • 36. Relapse — Locoregional therapy — After surgery: CCRT — After RT: possible surgery — After surgery and CCRT: platinum-based CT/BSC — Systemic therapy — Extrapelvic or para-aortic recurrence(s) at multiple sites or with unresectable recurrence — Platinum-based CT/BSC — Surgery has limited role for isolated sites Ahmed Zeeneldin 36
  • 37. Palliative chemotherapy — Recurrent or metastatic disease — Not candidate for surgery or RT — Platinum-based (most active, RR 20-30%) — Compared with cisplatin: — Combinations : — Same QOL, little or no OS advantage — cisplatin/paclitaxel and — cisplatin/topotecan (category 1 for both) Ahmed Zeeneldin 37
  • 38. Cisplatin-paclitaxel cispaltin Cisplatin - pacliatxel IVB recurrent or 134 130 persistent SCC RR (CR) 19 (6)% 36 (15)% Median PFS 2.8 m 4.8 m (P < .001) Median OS 8.8 m 9.7 m (PNS) QOL same same Anemia/neutropenia more — Moore et al, J Clin Oncol 2004;22:3113-3119 Ahmed Zeeneldin 38
  • 39. Cisplatin- topotecan Cispaltin Cisplatin - topotecan 146 147 RR 13% 27% Median PFS 2.9 m 4.6 m (P=0.014) Median OS 6.5 m 9.4 m (P=0.017) QOL same same Anemia/neutropenia more — Long HJ et al, J Clin Oncol. 2005 Jul 20;23(21):4626-33. — Cis 50 mg/sm q 3w — Topo 0.75 mg/sm/d x 3 d q 3w — MVAC third arm was closed due to high mortality — Fisrt to show OS advantage Ahmed Zeeneldin 39
  • 40. — PATIENTS AND METHODS: — RCT of 3 regimens every 3 weeks doses in mg/m2 — paclitaxel 135 over 24 hours plus Cis 50 day 2 (PC); — vinorelbine 30 days 1 &8 plus Cis 50 day 1 (VC); — gemcitabine 1,000 day 1 &8 plus Cis 50 day 1 (GC); — topotecan 0.75 days 1, 2, &3 plus Cis 50 day 1 (TC). Ahmed Zeeneldin 40
  • 43. Conclusions •VC, GC, and TC are not superior to PC in terms of overall survival (OS). •However, the trend in RR, PFS, and OS favors PC. •Differences in chemotherapy scheduling, pre-existing morbidity, and toxicity are important in individualizing therapy. Ahmed Zeeneldin 43