Author of

• 11645

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  P2.08 - Poster Session 2 - Radiotherapy (ID 198)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Radiation Oncology + Radiotherapy
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11664

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    P2.08-019 - Palliative radiation during pemetrexed plus cisplatin first-line treatment or pemetrexed continuation maintenance treatment in advanced nonsquamous non-small cell lung cancer (NSCLC): A report of patient safety in the PARAMOUNT trial (ID 2364)

    09:30 - 09:30  |  Author(s): B. San Antonio
    • Abstract

    Background
    Patient (pt) safety is of utmost concern to radiation oncologists. Pemetrexed (Pem) is an effective and well-tolerated treatment for advanced nonsquamous NSCLC. The safety of palliative radiation (XRT) during Pem treatment was studied in this subset of pts in the PARAMOUNT trial.

    Methods
    In PARAMOUNT, a randomized, double-blind study, 939 pts received 4 cycles of induction Pem (500 mg/m[2]) + cisplatin (Cis) (75 mg/m[2]) on day 1 every 21 days. Patients without progressive disease (PD) and with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0/1 (n=539) were then randomized (2:1) to maintenance Pem (500 mg/m[2], day 1) + best supportive care (BSC) (Arm A) or placebo + BSC (Arm B) until PD. Best supportive care (BSC) was defined as treatment without a specific antineoplastic regimen and included palliative XRT to extrathoracic structures. Safety was assessed via the incidence of adverse events (AEs) by maximum grade (Gr; CTCAE, v3).

    Results
    The 55 pts who received palliative XRT to extrathoracic structures during treatment had stage IV nonsquamous NSCLC. The majority of pts were male (58%), with an ECOG PS of 1 (75%). Patients’ median age was 61 yrs (range, 32-74) yrs, with 13% of pts ≥70 yrs. The most common location irradiated was bone (43/55 pts). Non-bone locations were: lymph node (3), mediastinum (2), chest (2), and adrenal gland, intraocular, lung, brain, and abdomen (1 each). Forty-five pts received XRT during Pem+Cis induction, 3 of whom also received XRT during maintenance. Seven pts (Arm A) and 6 pts (Arm B) received palliative XRT during maintenance. Total XRT doses ranged from 8-66 Gy. The time interval between day 1 of last chemotherapy cycle and the start of palliative XRT ranged from 0-28 days. Of 55 pts, 12 (22%) had ≥1 AE(s) during XRT considered possibly related to Pem and/or XRT (Table 1). All pts except 1 experienced the AE during induction. The most common AE was Gr 2 anemia. Three pts had Gr 3/4 anemia. Five pts had nonhematologic toxicities. One pt in Arm B, who received a total dose of 20 Gy in the hip during maintenance treatment, had pneumonitis. No AEs were reported for pts who received palliative XRT during Pem maintenance treatment.

    Table 1: AEs during palliative XRT or within 2 weeks after the end of the last fraction in both phases of the PARAMOUNT trial.
    Pts receiving palliative XRT (N=55)
    Patients with AEs during induction and/or maintenance (n=12, 22%)
    Toxicity	Gr 1, n (%)	Gr 2, n (%)	Gr 3-4, n (%)
    Hematologic
    Hemoglobin	1 (1.8)	4 (7.3)	3 (5.5)
    Leukocytes	0	2 (3.6)	1 (1.8)
    Platelets	0	1 (1.8)	0
    Nonhematologic
    Rash/dermatitis	1 (1.8)	1 (1.8)	0
    Rash/desquamation	1 (1.8)	1 (1.8)	0
    Pneumonitis	0	0	1 (1.8)*
    *Pneumonitis was the only event reported for a pt during the maintenance phase. The pt was assigned to placebo.

    Conclusion
    Conclusions: In PARAMOUNT, palliative XRT is well tolerated and can be safely administered at low and high doses during Pem+Cis chemotherapy or Pem monotherapy to pts with advanced nonsquamous NSCLC.