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Ovarian Cancer > Management of recurrent EOC > Flashcards

Management of recurrent EOC Flashcards

1
Q

There are three biologies for HGS recurrent ovarian cancer. What are they?

A
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2
Q

What are treatment options for platinum sensitive recurrence?

-Also give the treatment options

A

Platinum + Paclitaxel

  • ICON4: PFS 12 months vs 9 months (platinum only); survival advantage (OS 29 vs 24 months)

Carboplatin + gemcitabine

  • AGO: PFS 8.6 months vs 5.8 months (carbo only)

PLD + Trabectedin

  • OVA-301: PFS 9.2 vs 7.5 months (PLD only)

Carboplatin + PLD

  • CALYPSO: PFS 11.3 vs 9.4 months (Carbo+taxol)

Carbo/Gem/Bev

  • OCEANS: PFS: 12.4 vs 8.4 months (Carbo/Gem)

Carbo/Taxol/Bev

  • GOG 213: PFS 13.8 vs 10.4 months (carbo/taxol); survival advantage (OS 42.2 vs 37.3 months)

Platinum/Paclitxel/Cediranib (concurrent +/- maintenance)

  • ICON6: PFS 11.1 (chemo + cediranib + maintenance cediranib) vs 10.1 (chemo + cediranib) vs 8.7 months (platinum/taxol); survival advantage between maintenance vs chemo (OS 26.3 vs 20.3 months)
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3
Q

Discuss AURELIA and the results

A

Methods

Eligibility

  • Platinum-resistant ovarian cancer
  • <3 prior lines
  • No refractory disease, hx bowel obstruction

Investigator selected chemotherapy

  • pegylated liposomal doxorubicin
  • weekly taxol
  • topotecan

Randomized +/- bev until progression, unacceptable toxicity, or consent withdrawal.

Crossover to single-agent bevacizumab was permitted after progression with chemotherapy alone.

The primary end point was PFS.

Secondary end points included ORR, OS, safety, and PROs.

Results

ORR:11.8% vs 27.3% (P = .001).

OS

  • HR: 0.85 (95% CI, 0.66 to 1.08; P < .174)
  • mOS: 13.3 vs 16.6 months, respectively

Safety

  • Grade ≥ 2 hypertension and proteinuria were more common with bevacizumab.
  • GI perforation occurred in 2.2% of bevacizumab-treated patients.
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4
Q

Summary slide of treatment options for platinum-resistant recurrence

A
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5
Q
A
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6
Q

What was AGO Desktop III?

what were the results?

A
  • RCT
  • Eligibility: 1st relapse, Plat-sensitive OVCA, AGO score +ve
  • 2ndary cyto + platinum-based chemo vs platinum-based chemo only
  • Results
    • Survival advantage with surgery (see figure)
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7
Q

What are considerations for treatment planning for patients who recur?

A
  • Treatment free interval
  • Residual toxicity from prior therapy
  • Volume of disease at the time of relapse
  • Serologic relapse (CA-125)
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8
Q

What was SOC-1 and the design?

Was there any difference in the primary outcomes?

A

Prelim results show no difference in OS:

  • surgery (58 mo) vs no surgery (54 mo)
  • HR 0.82 (0.57 - 1.19)

PFS was added as a primary outcome:

  • mPFS 17.4 (surgery) vs 11.9 (no surgery) months
  • HR: 0.58 (95% CI 0.45 - 0.74; p <0.0001)

imodel score was based on 6 variables:

  1. FIGO stage
  2. residual disease after PCS
  3. PFS
  4. ECOG
  5. CA-125 at recurrence
  6. Presence of ascites at recurrence

Source: Tian WJ, Ann Surg Oncol 2012,19(2):597-604

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9
Q

What’s the role of bevacizumab in platinum-sensitive recurrence for maintenance therapy?

A
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10
Q

Therapies when platinum is not an option?

A
  • Weekly paclitaxel (+/- bevacizumab)
  • Pegylated liposomal doxorubicin (PLD) (+/- bevacizumab)
  • Cisplatin and gemcitabine, gemcitabine alone
  • Topotecan (+/- bevacizumab)
  • Pemetrexed
  • Metronomic cyclophosphamide
  • PARP inhibition (HR Deficient)
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11
Q

What is the definition of platinum-sensitivity?

A
  • The 6-months timeframe as a definition for platinum-sensitive vs platinum-resistant ovarian cancer patients is primarily for clinical trial purposes.
  • Sensitivity and resistance to platinum is better viewed as a continuum.
  • The definitions shown here for sensitivity were developed based on measurable ovarian cancer at first relapse and did not take into account CA-125 levels.
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12
Q

What are the endpoints and goals for treatment of platinum-recurrent OVCA?

A
  • Treatment to progression
  • Unacceptable toxicity
  • Complete clinical remission
  • Goal of palliation
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13
Q

How does platinum-free interval (PFI) correlate with second-line therapy efficacy?

A

Longer the PFI –> Better Response, better OS/PFS

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14
Q

Summary Slide trial designs of GOG-213 vs Desktop III vs SOC-1

A
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15
Q

What are treatment options for ovarian cancer patients with relapse after 6 months following frontline therapy?

A
  • Depends on radiographic/and or clinical relapse vs biochemical relapse (CA-125 elevated with no radiologic evidence of disease)
  • Treatment options
    • Consider secondary cytoreduction
    • Combination-platinum based chemo
    • Clinical trial
    • Consider delay treatment until clinical relapse if only biochemical relapse
    • Best supportive care (unlikely)
    • Combination of methods
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16
Q

What is the AGO-score?

A

AGO-score +ve if contains all 3:

  • PS ECOG 0
  • ascites ≤500 ml
  • complete resection at initial surgery
17
Q

What are the takeaways from GOG-213 vs Desktop III vs SOC-1?

What’s the bottom line about secondary cytoreduction?

A
  1. Takeaways
    • Criteria for patient selection was reasnable across studies (>=66 CGR) but better with validated tools
    • Impact of surgery of PFS and OS remarkably consistent across all 3 trials
    • Desktop III and SOC-1 have similarly performing control arms
      • Desktop III prognostically more favorable
    • Outlier is GOG-213’s control arm
      • Much higher use of bevacizumab (demonstrated in several trials to be superior to chemotherapy alone)
  2. Bottom line
    • Secondary cytoreduction
      • clear selection criteria are necessary
      • Goal should always be R0
      • Bevacizumab is the great equalizer
18
Q

When do patients with advanced EOC recur?

A

Most patients recur between 18 - 24 months

19
Q

Summary of survival outcomes of GOG-213 vs Desktop III vs SOC-1

A
20
Q

For the current FDA-approved treatment options for platinum-sensitive recurrence:

  • median PFS range?
  • CR rate and duration?
  • Platinum-based doublets and treatments to consider the most?
A
  • 8.4 - 12 months
  • 20% with >50% more than 6 months DOR
    • Platinum-based doubles with PLD, Gemcitabine, and Paclitaxel; bevacizumab for most
21
Q

What was GOG 213?

what were the results?

A

GOG 213 (n = 485)

  • RCT to assess 2ndary cytoreduction in platinum-sensitive recurrent OVCA
    • Investigator-determined resectable disease (to R0)
    • adjuvant chemo carbo/taxol +/- bev (investigator-discretion)
    • 2ndary cytoreduction + chemo vs chemo only
    • Primary Endpoint = OS
  • Results
    • R0 in 67% of patients
    • F/U 48.1 months
    • Bev in 84% of patients overall
    • No difference in OS/PFS
22
Q

What are surgical trials for recurrent ovarian cancer?

What were their endpoints?

A
23
Q

PFI is now replaced with what?

A
  • Platinum-free interval is no longer the only factor to consider when selecting therapy
  • The historical definition of using platinum-free interval (PFI) to categorize patients as having platinum-sensitive or resistant disease is now replaced by therapy-free interval (TFI)
    • Patients for whom platinum is an option (formerly platinum-sensitive)
    • Patients for whom platinum is not an option (formerly platinum-resistant)
24
Q

1) What proportion of patients with advanced EOC will recur after initial therapy?

A) Overall?

B) they initially have large-volume advanced disease?

C) What about small-volume advanced disease?

2) What if they have limited disease?

A) high-risk limited disease?

B) low-risk limited?

A

1)

A) 60 - 80%

B) 80 - 95%

C) 60 - 70%

2)

A) 20%

B) 10%

25
Q

What proportion of advanced EOC patients will have persistent disease or be refractory to frontline therapy?

A

20%

Ovarian Cancer (8 decks)

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