DR SPIGEL: This is an 82-year-old woman who actually is pretty active. She has a new granddaughter and cares for her through the week while her son-in-law and daughter work. So she’s not restricted in any way. She’s very busy. But she had been diagnosed with advanced squamous lung cancer a few years prior and was actually taken care of by a colleague in the community, and had received chemotherapy.
She had advanced disease, so she had obvious lung involvement with skeletal extension as well but no brain involvement, no clinical symptoms really from it, other than some occasional pain and fatigue. Those were really her main complaints.
DR LOVE: So at the time you saw her, how many lines of therapy had she had, and what was her situation?
DR SPIGEL: She’d been through 2 prior lines of systemic therapy, so she’d received a platinum doublet. So at that time she’d received carboplatin and paclitaxel. And then she went on to receive gemcitabine. Her oncologist had given her that. And that’s when I got the phone call, would I mind seeing her for another opinion. She had progressed through those therapies over a course of about 18 months.
DR LOVE: And what was her quality of life, and her lifestyle at that point? And what was on her mind?
DR SPIGEL: I think she had grown a little bit skeptical about the value of systemic therapy, of chemotherapy, that here she had tried 2 rounds of therapy without much benefit and yet was willing to try other things. Again, she had a new granddaughter, so she wanted to be around if there was a chance that some therapy could extend her life and ease the progression of this cancer. I think she was interested in trying that. It’s worth mentioning her son-in-law, who’s fantastic, is a paramedic. So he has a healthcare background. And so he was pushing, motivating his mother-in-law to seek additional opinions.
DR LOVE: And how long had she been living with metastatic disease?
DR SPIGEL: Just under 2 years.
She also mentioned she lives about 45 minutes outside of my office, so she was interested in hearing about things, but it would have to be pretty good for her to make the trip routinely to get her care.
DR LOVE: So she was coming in to find out about research options, but not —
DR SPIGEL: Pushed by her son-in-law.
DR LOVE: But kind of skeptical, whether she was going —
DR SPIGEL: Right.
DR LOVE: — to go for it.
DR SPIGEL: Very skeptical. So we reviewed a lot of options with her, and at that time we had just opened an expansion arm of nivolumab, a Phase I study, actually, that was recruiting patients with squamous cancer. And so this is a single cohort option for her. There was no PD-L1 expression required, so there was no marker required to get onto this study. She did have to have archived tissue.
So I discussed this option with her and her son-in-law, and she said, “Yeah. I’ll try that.”
DR LOVE: Did she end up having a PD-L1, incidentally?
DR SPIGEL: So that’s unknown because —
DR LOVE: Oh, you don’t know?
DR SPIGEL: — that tissue has been — is centrally tested, and those results have not been released. So she went on a therapy that was every 2 weeks. So she was not very pleased about that, that proposition. But when I told her that we didn’t expect side effects to be large, probably more constitutional in nature, she was willing to pursue this.
DR LOVE: I’m just kind of curious: Was she asking you a lot of questions, or she pretty much knew she was not in a good situation?
DR SPIGEL: She was very — I mean, she’s an 82-year-old woman looking at a doctor who’s telling her about more treatment for lung cancer. And so I was — to me, she’s like a school teacher. I was very nervous, always going into — I still am, when I see her. Because she always puts me in my place and tells me, “This better be worth it.” So she’s very skeptical. And I’m realistic that I don’t have a great track record with patients doing well on third-line therapy with squamous lung cancer.
DR LOVE: And at that point, I guess we didn’t really have much data — or any data, I guess.
DR SPIGEL: No, no data.
DR LOVE: So this is just another Phase I study, in a way.
DR SPIGEL: A Phase I study with some anecdotes that people were excited.
DR LOVE: What happened with this lady?
DR SPIGEL: So she elected to enroll in this study. And so she went onto every 2-week therapy. And in the beginning, she did have to come more often, and I certainly got an earful at each visit about, “Why am I here? Why do I have to keep going through this?” And it became kind of a joke in our clinic because this patient would come and she would pace outside her room, waiting for me to come in, because she was having no symptoms. And she was feeling better. And I told you about her granddaughter. Frequently, her granddaughter was in the room with her, waiting for her to get done.
DR LOVE: Was she having symptoms from the disease when you started therapy?
DR SPIGEL: We were worried about worsening fatigue. We were worried about some cough that was nagging her. Her son-in-law was very worried about her cough.
DR LOVE: What was her chest situation in terms of tumor? Did she have pleural —
DR SPIGEL: She had bilateral disease. No effusions, but bilateral disease. I mean, it was clear that if she was going to have any symptoms, they were going to be respiratory in nature.
DR LOVE: So she had enough disease that you were suspicious it was actually causing symptoms at that point.
DR SPIGEL: Right. It was noticeable in the room that she was coughing through the visits.
DR LOVE: And what happened as she got treated?
DR SPIGEL: Kind of an unusual thing — and take it for what it is. It’s 1 patient. But it became unlike anything I’ve seen, where I go into a room and someone has no symptoms at all, and we’re now 3 months, 6 months, 9 months, 12 months into treatment.
DR LOVE: What was going on objectively?
DR SPIGEL: Her scans continued to show small — what would I call minor responses. She certainly did not have dramatic improvement or disappearing — clearance of her lungs. But over time there was gradual improvement in her lungs. And what her son-in-law and I noticed is that the cough went away. And her only complaint was coming in for the visits. “Why do I have to keep coming to see you, if I’m feeling so well?”
So we pushed ahead, and this summer we reached 24 months, 2 years. And the trial was written that at the 2-year point patients actually go off study if they’re doing well, with the option to go back on treatment at progression. And so she was very happy, and yet nervous about this proposition. Her son-in-law was very nervous. And we talked through about how well she had done. Her scans were looking — continue to look good. She still has disease we can see. She didn’t pretend — or I didn’t pretend that she’s cured.
DR LOVE: Has she had what you would consider, your radiology people consider, an objective response, or not?
DR SPIGEL: She’s had a partial response.
DR LOVE: Partial response. Okay.
DR SPIGEL: So we stopped therapy earlier this summer. It’s been almost 6 months. I’ve seen her, and her evaluations, her visits now changed to much less frequently. I think she went 3 months before she had to come back in. And she continues to do very, very well. Her scans look good. She feels well. She’s off therapy now for many months. The big question is, what’s going on with her cancer? Is it going to come back? Is she going to start to feel bad? And will she need to go back on any treatment? And those are unknown answers.